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7 Tips to Comply With FDA 21 CFR Part 11 - Featured Image

7 Tips to Comply With FDA 21 CFR Part 11

By Jon Speer on January 15, 2020
When it comes to regulatory compliance for medical device companies, there can be some confusion aro...
5 Steps for Getting your CE Marking with EU MDR Requirements - Featured Image

5 Steps for Getting your CE Marking with EU MDR Requirements

By Tom Rish on January 12, 2020
It has long been thought that the quickest path to market for medical device manufacturers is to acc...
The Art of Defining Design Inputs And Design Outputs - Featured Image

The Art of Defining Design Inputs And Design Outputs

By Jon Speer on January 8, 2020
Design inputs are the king of medical device product development. If a product that is in the market...
15 Questions to Ask QMS Software Vendors in the Medical Device Industry - Featured Image

15 Questions to Ask QMS Software Vendors in the Medical Device Industry

By Jon Speer on January 5, 2020
As a medical device company, you are expected to deliver innovative, life-changing medical device(s)...
Medical Device Classification Guide - How To Determine Your Device Class - Featured Image

Medical Device Classification Guide - How To Determine Your Device Class

By Tom Rish on January 2, 2020
What I am about to share with you is a guide to medical device regulatory classification.
Top 10 Most Popular Greenlight Guru Posts of 2019 - Featured Image

Top 10 Most Popular Greenlight Guru Posts of 2019

By Nick Tippmann on December 29, 2019
Thank you for helping make 2019 another big and exciting year for Greenlight Guru!
Navigating the Twists and Turns of Change Management for Medical Devices - Featured Image

Navigating the Twists and Turns of Change Management for Medical Devices

By Nick Tippmann on December 28, 2019
Change is constant… Especially in the medical device industry. Medical device change management can ...
Top 40+ Medical Device Conferences To Attend in 2020 - Featured Image

Top 40+ Medical Device Conferences To Attend in 2020

By Nick Tippmann on December 20, 2019
Simply attending the right medical device conference can be a game-changer for those who work in the...
What Is FDA's ASCA Pilot Program And How Does It Impact Medical Device Manufacturers? - Featured Image

What Is FDA's ASCA Pilot Program And How Does It Impact Medical Device Manufacturers?

By Nick Tippmann on December 18, 2019
FDA announced the anticipated 2020 launch of a new pilot program known as the Accreditation Scheme f...
3 Pros and Cons to 3D Printing for Medical Devices - Featured Image

3 Pros and Cons to 3D Printing for Medical Devices

By Kayla Matthews on December 15, 2019
3D printing processes — which use digital models to create physical devices out of materials like pl...
5 Myths about QA/RA Recruiting in the Medical Device Industry - Featured Image

5 Myths about QA/RA Recruiting in the Medical Device Industry

By Nick Tippmann on December 11, 2019
Recruiting top, elite quality assurance and regulatory affairs (QA/RA) talent in the medical device ...
Greenlight Guru Announces Enhanced Change Management Capabilities - Featured Image

Greenlight Guru Announces Enhanced Change Management Capabilities

By Nick Tippmann on December 9, 2019
Medical device quality management system (MDQMS) improves traceability and efficiency associated wit...
How to Solve the Medtech Value Equation with Quality Data - Featured Image

How to Solve the Medtech Value Equation with Quality Data

By Nick Tippmann on December 4, 2019
Which medical technology, product, or device are you actively focused on bringing to market that wil...
8 Most Common Mistakes to Avoid with FDA 21 CFR Part 820 - Featured Image

8 Most Common Mistakes to Avoid with FDA 21 CFR Part 820

By Jon Speer on November 27, 2019
If you’re a medical device company selling or planning to sell into the US market, you should be fam...
Why Supplier Quality Management Is So Important - Featured Image

Why Supplier Quality Management Is So Important

By Nick Tippmann on November 27, 2019
Effectively managing suppliers, vendors, consultants, and other third party entities that provide pr...
State of Medical Device Product Development and Quality Management Report 2020 - Featured Image

State of Medical Device Product Development and Quality Management Report 2020

By Jon Speer on November 25, 2019
Greenlight Guru, the only medical device quality management system (MD QMS) software platform, today...
FDA is Expanding its Case for Quality Program... Should Your Company Participate? - Featured Image

FDA is Expanding its Case for Quality Program... Should Your Company Participate?

By Nick Tippmann on November 20, 2019
Depending on the level of quality and compliance, medical devices can impact patients’ lives for bet...
Definitive Guide to Change Management for Medical Devices - Featured Image

Definitive Guide to Change Management for Medical Devices

By Jon Speer on November 17, 2019
Preparing for EU MDR - Featured Image

Preparing for EU MDR

By Nick Tippmann on November 13, 2019
Do you have a regulatory strategy to help your company prepare for the new European Medical Device R...
Tips for Success with IEC 60601 for Electrical Medical Devices - Featured Image

Tips for Success with IEC 60601 for Electrical Medical Devices

By Wade Schroeder on November 10, 2019
Does your company develop electrical medical devices? The standard IEC 60601 is different from other...
Addressing Top Questions of QA/RA Candidates on Salary, Skill Sets and Job Satisfaction - Featured Image

Addressing Top Questions of QA/RA Candidates on Salary, Skill Sets and Job Satisfaction

By Nick Tippmann on November 6, 2019
Quality Assurance and Regulatory Affairs (QA/RA) professionals need to keep their finger on the puls...
EU MDR Implementation Guide - Featured Image

EU MDR Implementation Guide

By Michael Galliker on November 5, 2019
The European medical device industry will undergo significant changes as a result of the new medical...
How FDA Distinguishes Between Clearance vs. Approval vs. Granted - Featured Image

How FDA Distinguishes Between Clearance vs. Approval vs. Granted

By Tom Rish on November 3, 2019
As a medical device professional, you are well aware of how much time and effort goes into getting y...
The Ultimate Guide to the EU MDR General Safety and Performance Requirements (GSPR) - Featured Image

The Ultimate Guide to the EU MDR General Safety and Performance Requirements (GSPR)

By James Gianoutsos and Rod Beuzeval on October 20, 2019
C2DX, Inc. Impresses auditors and Breezes through MDSAP AUDIT After Implementing Medical Device QMS (MDQMS) - Featured Image

C2DX, Inc. Impresses auditors and Breezes through MDSAP AUDIT After Implementing Medical Device QMS (MDQMS)

By Nick Tippmann on October 17, 2019
  Experienced medical device professionals can agree that investing in quality early on and putting ...
Is FDA's New 'Safer Technologies Program' Applicable To Your Medical Device? - Featured Image

Is FDA's New 'Safer Technologies Program' Applicable To Your Medical Device?

By Nick Tippmann on October 16, 2019
FDA recently announced its new Safer Technologies Program (STeP), which intends to make medical devi...
7 Tips to Attract Investors and Raise Funds for your Medical Device - Featured Image

7 Tips to Attract Investors and Raise Funds for your Medical Device

By Jon Speer on October 13, 2019
Is your medical device company in the midst of raising funds or planning to begin the process? There...
Improving Outcomes and Reducing Costs with an Intelligent Surgical Medical Device - Featured Image

Improving Outcomes and Reducing Costs with an Intelligent Surgical Medical Device

By Nick Tippmann on October 11, 2019
Surgery can be a challenging experience, not only for patients, but their clinicians and caregivers,...
5 Do's and Don'ts when Choosing a QMS Solution for your Medical Device Company - Featured Image

5 Do's and Don'ts when Choosing a QMS Solution for your Medical Device Company

By Jon Speer on October 6, 2019
As a medical device manufacturer, your quality management system is the heart of your operations. 
Understanding the Benefit-Risk Determinations of FDA's Latest Guidance Documents - Featured Image

Understanding the Benefit-Risk Determinations of FDA's Latest Guidance Documents

By Nick Tippmann on October 2, 2019
If you haven’t realized it yet, risk management in the medical device industry isn’t going away. How...
4 Biggest Challenges in Medical Device Manufacturing (and how to overcome them) - Featured Image

4 Biggest Challenges in Medical Device Manufacturing (and how to overcome them)

By QRA Corp on September 29, 2019
Effective planning is the key to success for any business but to an even greater degree in the medic...
Leveraging Technology and Rapid Prototyping Methodologies during Product Development - Featured Image

Leveraging Technology and Rapid Prototyping Methodologies during Product Development

By Nick Tippmann on September 25, 2019
Do you know everything there is to know about prototyping, product iteration, and manufacturing to g...
Complete Guide to Bringing a Medical Device to Market - Featured Image

Complete Guide to Bringing a Medical Device to Market

By Tom Rish on September 22, 2019
Best Practices for Expediting Your Product Development - Featured Image

Best Practices for Expediting Your Product Development

By Jon Speer on September 15, 2019
Speed to market is one of the major challenges for medical device companies. So, how can you expedit...
Why Design Verification Matters in Medical Device Design and Development - Featured Image

Why Design Verification Matters in Medical Device Design and Development

By Nick Tippmann on September 11, 2019
Design verification can be a difficult stage for medical device companies to carry out effectively. ...
5 Tips from MedTech Executives on the Value of Quality - Featured Image

5 Tips from MedTech Executives on the Value of Quality

By Jon Speer on September 8, 2019
When it comes to making medical devices, quality is key.
Implementing Changes to SaMD under New EU MDR - Featured Image

Implementing Changes to SaMD under New EU MDR

By Nick Tippmann on September 4, 2019
Classification, qualification, and other changes to Software as a Medical Device (SaMD) under the ne...
Career Tips for QA/RA Professionals in the Medical Device Industry - Featured Image

Career Tips for QA/RA Professionals in the Medical Device Industry

By Nick Tippmann on August 28, 2019
Medical device quality and regulatory professionals face changes, challenges, requirements, standard...
Why the FDA Pre-Submission is an Underutilized Tool - Featured Image

Why the FDA Pre-Submission is an Underutilized Tool

By Jon Speer on August 25, 2019
“I wish there was a way for the FDA to give me a feedback about my medical device, prior to submissi...
Right-sizing your QMS - Featured Image

Right-sizing your QMS

By Nick Tippmann on August 21, 2019
Is your quality management system (QMS) right-sized to fit with the people, processes and purpose of...
Photonicare Adopts Medical Device QMS Software to Accelerate Time to Market - Featured Image

Photonicare Adopts Medical Device QMS Software to Accelerate Time to Market

By Nick Tippmann on August 19, 2019
How to Evaluate a Company’s Regulatory and Quality ‘Health’ Before Investing - Featured Image

How to Evaluate a Company’s Regulatory and Quality ‘Health’ Before Investing

By David Amor on August 18, 2019
When asked whether he hires consultants to help him make investment decisions in the MedTech space, ...
Challenges with Pediatric Medical Devices - Featured Image

Challenges with Pediatric Medical Devices

By Nick Tippmann on August 14, 2019
Challenges continue with the design and development of pediatric medical devices.
13 Tips For Audit Etiquette Every Medical Device Company Should Know - Featured Image

13 Tips For Audit Etiquette Every Medical Device Company Should Know

By Taylor Brown on August 11, 2019
I love audits. Seriously! It is a hybrid experience, like a kindergarten show-and-tell with a classi...
Elevating True Quality with Software as a Medical Device for Early Cancer Detection and Treatment - Featured Image

Elevating True Quality with Software as a Medical Device for Early Cancer Detection and Treatment

By Nick Tippmann on August 9, 2019
In the U.S. alone, over 80% of the 5,000 biopsies conducted daily come back either falsely negative,...
When Should You Start a QMS? - Featured Image

When Should You Start a QMS?

By Nick Tippmann on August 7, 2019
Early-stage startups often wonder when the right time is to consider a quality management system (QM...
Ultimate Guide to Agile Design and Development for Medical Devices - Featured Image

Ultimate Guide to Agile Design and Development for Medical Devices

By Agile Medical Device Design (AMDD) on August 4, 2019
                                Table of Contents   Overview - Agile Design and Development for Medi...
How General Wellness Devices Have Opened a Pandora's Box of Confusion - Featured Image

How General Wellness Devices Have Opened a Pandora's Box of Confusion

By Nick Tippmann on July 31, 2019
Do you have a Fitbit, Apple Watch, or other general wellness device to track your activity, monitor ...
What is a Quality Culture? (and 7 tips for creating one) - Featured Image

What is a Quality Culture? (and 7 tips for creating one)

By Jon Speer on July 28, 2019
In the medical device industry, the word quality can mean different things to different people. To s...
A Firsthand Account of the Origins and Outcomes of FDA's Case For Quality and MDDAP - Featured Image

A Firsthand Account of the Origins and Outcomes of FDA's Case For Quality and MDDAP

By Nick Tippmann on July 26, 2019
Patients, providers, and companies are already experiencing the benefits of FDA’s Case for Quality P...
Regulating Artificial Intelligence and Machine Learning-Based Software as a Medical Device - Featured Image

Regulating Artificial Intelligence and Machine Learning-Based Software as a Medical Device

By Nick Tippmann on July 24, 2019
Artificial intelligence (AI) and machine learning (ML) seem to be involved in everything, including ...
6 Most Common Mistakes When Implementing ISO 13485 - Featured Image

6 Most Common Mistakes When Implementing ISO 13485

By Jon Speer on July 21, 2019
Companies must establish and maintain a quality management system in order to ensure they are produc...
Importance of Software Requirements in Product Development - Featured Image

Importance of Software Requirements in Product Development

By Nick Tippmann on July 17, 2019
Software and other requirements are critically important to medical device product development.
Everything You Need To Know To Perform Effective Root Cause Analysis - Featured Image

Everything You Need To Know To Perform Effective Root Cause Analysis

By Jon Speer on July 14, 2019
Picture this: something goes wrong with a medical device, and a complaint is issued. In a post-marke...
Eliminating Subjectivity and Guesswork with a Modernized Solution to Detecting Ear Infections - Featured Image

Eliminating Subjectivity and Guesswork with a Modernized Solution to Detecting Ear Infections

By Nick Tippmann on July 12, 2019
If you or your child have ever experienced ear infections, you know how difficult (and painful) they...
4 Facts That May Surprise You About FDA - Featured Image

4 Facts That May Surprise You About FDA

By Nick Tippmann on July 10, 2019
From creating product codes to following regulations, do you ever wonder what goes on inside the U.S...
Should you Swipe Right or Left on your Notified Body? - Featured Image

Should you Swipe Right or Left on your Notified Body?

By Michelle Lott on July 7, 2019
How long have you been dating your Notified Body – “NB” for short? Is your eye beginning to wander? ...
Design History File Ready Ideation: An Innovative Approach to Product Development - Featured Image

Design History File Ready Ideation: An Innovative Approach to Product Development

By Nick Tippmann on July 3, 2019
As a medical device professional, do you know about Design History File Ready Ideation (DHFRI)?
Why I Used To Hate Risk Management (And 3 Ways to Change Your Mind Too) - Featured Image

Why I Used To Hate Risk Management (And 3 Ways to Change Your Mind Too)

By Jesseca Lyons on June 30, 2019
I hate Risk Management. There, I said it. And I’m not the only one actually. We’re all thinking it. ...
Looking at the Sunset of FDA's Alternative Summary Reporting Program - Featured Image

Looking at the Sunset of FDA's Alternative Summary Reporting Program

By Nick Tippmann on June 26, 2019
The FDA recently decided to discontinue its alternative summary reporting program due to the allegat...
Creating a Culture of Quality for Medical Device Companies - Featured Image

Creating a Culture of Quality for Medical Device Companies

By Nick Tippmann on June 21, 2019
Is creating a culture of quality a top priority at your MedTech company? But you’re not sure how or ...
Challenges with MedTech Innovation - Featured Image

Challenges with MedTech Innovation

By Nick Tippmann on June 19, 2019
The medical device industry strives to develop high quality and innovative products that will contri...
FDA QSIT: Preparing Your Medical Device Company for an Inspection - Featured Image

FDA QSIT: Preparing Your Medical Device Company for an Inspection

By Jon Speer on June 17, 2019
Preparing for an FDA QSIT inspection can be a daunting task for medical device manufacturers. Many c...
Is Your Medical Device Company CAPA Happy? - Featured Image

Is Your Medical Device Company CAPA Happy?

By Nick Tippmann on June 12, 2019
The medical device industry could be more proactive than reactive when managing systemic issues. We’...
10 Essentials for Writing a Clear Product Requirements Document [Guide+Checklist] - Featured Image

10 Essentials for Writing a Clear Product Requirements Document [Guide+Checklist]

By QRA Corp on June 9, 2019
We distilled the insights from our research into this one guide + checklist that we hope will help a...
Integrating Human Factors into Design Controls to Improve Patient Outcomes - Featured Image

Integrating Human Factors into Design Controls to Improve Patient Outcomes

By Nick Tippmann on June 5, 2019
The relationship between human factors and design controls often creates confusion in the medical de...
5 Most Common Mistakes Made When Implementing ISO 14971 - Featured Image

5 Most Common Mistakes Made When Implementing ISO 14971

By Jon Speer on June 2, 2019
ISO 14971 is a descriptive regulatory standard that provides guidance for how to apply risk manageme...
Greenlight Guru In the Classroom: A University's Real-world Approach - Featured Image

Greenlight Guru In the Classroom: A University's Real-world Approach

By Nick Tippmann on May 29, 2019
Greenlight Guru continues to bridge the gap in biomedical engineering education by helping students ...
The Essential Guide to Preparing your QMS for EU MDR - Featured Image

The Essential Guide to Preparing your QMS for EU MDR

By Jon Speer on May 27, 2019
How prepared is your quality management system for the new requirements of EU MDR for medical device...
Improving the Colon Cancer Screening Experience - Featured Image

Improving the Colon Cancer Screening Experience

By Nick Tippmann on May 24, 2019
Preparation for a colonoscopy is not a pleasant or positive experience. From laxatives to the invasi...
EU MDR: Not All Doom and Gloom - Featured Image

EU MDR: Not All Doom and Gloom

By Nick Tippmann on May 22, 2019
Feeling gloom, doom, concern, and fear about the new European Union Medical Device Regulation (EU MD...
Qualifying Your Suppliers Using a Risk-based Approach - Featured Image

Qualifying Your Suppliers Using a Risk-based Approach

By Jon Speer on May 19, 2019
This notion of risk-based processes within quality systems is something that has become part of our ...
Biocompatibility Nuances and its Impact on Medical Devices - Featured Image

Biocompatibility Nuances and its Impact on Medical Devices

By Nick Tippmann on May 15, 2019
Biocompatibility can be challenging and frustrating when developing a medical device. Why do you hav...
How to Write Effective SOPs for Medical Devices - Featured Image

How to Write Effective SOPs for Medical Devices

By Jon Speer on May 12, 2019
Writing and enforcing standard operating procedures (SOPs) for medical devices is required by FDA, I...
Advancing MRI Technology As We Know It Today - Featured Image

Advancing MRI Technology As We Know It Today

By Nick Tippmann on May 10, 2019
The field of radiology is constantly changing and evolving overtime. One MedTech innovator who's lea...
How to Make De Novo a Viable Option for your Medical Device - Featured Image

How to Make De Novo a Viable Option for your Medical Device

By Nick Tippmann on May 9, 2019
Is de novo a realistic regulatory pathway? Or, the “kiss of death” for your product? No, to de novo?...
8 Questions About the European MDR Answered - Featured Image

8 Questions About the European MDR Answered

By Jon Speer on April 30, 2019
The European Medical Device Regulation (MDR) is a new set of regulations that governs the production...
How a Shift in Mindset Resulted in a Higher Quality IQ for this Industry Veteran - Featured Image

How a Shift in Mindset Resulted in a Higher Quality IQ for this Industry Veteran

By Nick Tippmann on April 26, 2019
Within the medical device industry, there’s a right way and a wrong way to address quality and compl...
The 100th Episode: A Few of My Favorite Moments - Featured Image

The 100th Episode: A Few of My Favorite Moments

By Nick Tippmann on April 25, 2019
Drumroll, please. It’s time to celebrate the 100th episode of the Global Medical Device Podcast!
Top 50 Medical Device Product Design and Development Companies - Featured Image

Top 50 Medical Device Product Design and Development Companies

By Nick Tippmann on April 21, 2019
Medical device companies have to overcome many significant challenges when bringing a new product to...
Live Atlanta True Quality Roadshow Panel: The Changing Quality & Regulatory Paradigm - Featured Image

Live Atlanta True Quality Roadshow Panel: The Changing Quality & Regulatory Paradigm

By Nick Tippmann on April 19, 2019
Do you love quality and regulatory and keeping up with all things related to the medical device indu...
De Novo Pathway: Explaining the Process for Medical Device Companies - Featured Image

De Novo Pathway: Explaining the Process for Medical Device Companies

By Jon Speer on April 14, 2019
The De Novo pathway has been around for more than two decades, but it is still one of the least used...
Grasping the Impact of Artificial Intelligence and Machine Learning on Medical Devices - Featured Image

Grasping the Impact of Artificial Intelligence and Machine Learning on Medical Devices

By Nick Tippmann on April 11, 2019
It seems like every time you turn on the TV, there’s commercials, movies, and shows that highlight t...
Greenlight Guru Launches New Podcast Series: MedTech True Quality Stories - Featured Image

Greenlight Guru Launches New Podcast Series: MedTech True Quality Stories

By Jon Speer on April 7, 2019
  I'm thrilled to announce the officially launch of Greenlight Guru's second podcast series, MedTech...
How Sonavex Went from Concept to FDA Clearance in Just 3 Years - Featured Image

How Sonavex Went from Concept to FDA Clearance in Just 3 Years

By Nick Tippmann on April 7, 2019
How do medical device companies approach the “scaries” related to quality and guidance regulations w...
Improving the Quality of Life in the Most Delicate Patient Group: Preterm Born Infants - Featured Image

Improving the Quality of Life in the Most Delicate Patient Group: Preterm Born Infants

By Nick Tippmann on April 7, 2019
Premature birth is the #1 cause of infant mortality in the United States. Improving the quality of l...
ISO 13485 Medical Device Quality System Standard and Other Regulatory Conundrums - Featured Image

ISO 13485 Medical Device Quality System Standard and Other Regulatory Conundrums

By Edwin Bills, ASQ Fellow, RAC on April 1, 2019
The 2003 edition of ISO 13485 has now been withdrawn and fully replaced by the 2016 edition.[i]  As ...
Case Study: Centese ditches paper-based QMS AND achieves FDA 510(k) clearance - Featured Image

Case Study: Centese ditches paper-based QMS AND achieves FDA 510(k) clearance

By Nick Tippmann on March 29, 2019
For many early-stage medical device companies, the default option when implementing a quality manage...
Case Study: How Innovere Accelerated Their Path To Market By Implementing Greenlight Guru’s Medical Device eQMS - Featured Image

Case Study: How Innovere Accelerated Their Path To Market By Implementing Greenlight Guru’s Medical Device eQMS

By Nick Tippmann on March 28, 2019
    Advanced magnetic resonance imaging (MRI) technology has become an important piece of healthcare...
Modernizing 510(k) Program through new FDA Safety and Performance Based Pathway - Featured Image

Modernizing 510(k) Program through new FDA Safety and Performance Based Pathway

By Nick Tippmann on March 27, 2019
FDA recently released a new guidance document titled, Safety and Performance Based Pathway, which pe...
Why Document Control Matters To Medical Device Companies - Featured Image

Why Document Control Matters To Medical Device Companies

By Jon Speer on March 24, 2019
As medical device professionals, we share a common goal of producing safe and effective medical devi...
Abbreviated 510(k): Substantial Equivalence Through Performance Criteria - Featured Image

Abbreviated 510(k): Substantial Equivalence Through Performance Criteria

By Jon Speer on March 17, 2019
A recent draft guidance document was published by FDA detailing the expansion of the Abbreviated 510...
The Greenlight Guru True Quality Roadshow: Atlanta Recap - Featured Image

The Greenlight Guru True Quality Roadshow: Atlanta Recap

By Nick Tippmann on March 15, 2019
We’re back from the peach state and an evening at The Gathering Spot in Atlanta for The Greenlight G...
Lucerno Dynamics Has Simplified the ISO 13485:2016 Certification Process With Greenlight Guru - Featured Image

Lucerno Dynamics Has Simplified the ISO 13485:2016 Certification Process With Greenlight Guru

By Nick Tippmann on March 13, 2019
In a world of rapidly changing regulatory requirements, achieving new certifications, such as ISO 13...
Case Study: How AMNION LIFE IS LAYING THE FOUNDATION FOR SUCCESS WITH GREENLIGHT GURU - Featured Image

Case Study: How AMNION LIFE IS LAYING THE FOUNDATION FOR SUCCESS WITH GREENLIGHT GURU

By Nick Tippmann on March 12, 2019
The majority of medical device companies operate on an emphasis of high quality outcomes and scalabi...
Why Flexible Design Reviews Matter for Medical Device Product Development - Featured Image

Why Flexible Design Reviews Matter for Medical Device Product Development

By Jon Speer on March 10, 2019
It is my humble and expert opinion that the medical device industry has the most significant impact ...
Nonbinding Feedback is a New Guidance You Should Know About - Featured Image

Nonbinding Feedback is a New Guidance You Should Know About

By Nick Tippmann on March 8, 2019
FDA has been busy working on guidance documents, including Nonbinding Feedback After Certain FDA Ins...
Greenlight Guru Announces Digital Design Reviews for Medical Device Product Development Teams - Featured Image

Greenlight Guru Announces Digital Design Reviews for Medical Device Product Development Teams

By Nick Tippmann on March 5, 2019
Medical device quality management system debuts flexible design review capabilities for devices with...
How and When to Consider Human Factors - Featured Image

How and When to Consider Human Factors

By Nick Tippmann on February 28, 2019
When should you begin to consider human factors with your medical device design and development effo...
Quality, Fast, Cheap...Pick Two - Featured Image

Quality, Fast, Cheap...Pick Two

By Mark D Proulx, CQA, cSSBB on February 24, 2019
You may think you're saving the company money by using that "free" Excel spreadsheet to track design...
Who Should Own Your QMS? - Featured Image

Who Should Own Your QMS?

By Nick Tippmann on February 21, 2019
Does your medical device company prefer to outsource the responsibility of its quality management sy...
What to Expect During an FDA QSIT Inspection - Featured Image

What to Expect During an FDA QSIT Inspection

By Jon Speer on February 17, 2019
You arrive at work one morning and there are FDA inspectors sitting in your waiting area. If you are...
Design Validation vs. Human Factors Validation - Featured Image

Design Validation vs. Human Factors Validation

By Nick Tippmann on February 13, 2019
  Human factors and risk create a lot of confusion in the medical device industry. What do you need ...
5 Most Common Problems with your CAPA Process - Featured Image

5 Most Common Problems with your CAPA Process

By Jon Speer on February 10, 2019
Year after year, the corrective and preventive action (CAPA) process continues to be the most widely...
Medical Device Product Development Value Proposition - Featured Image

Medical Device Product Development Value Proposition

By Nick Tippmann on February 6, 2019
It doesn’t matter how long a company has been in business. Both startups and established companies n...
Introducing The Greenlight Guru True Quality Roadshow 2019 - Featured Image

Introducing The Greenlight Guru True Quality Roadshow 2019

By Jon Speer on January 29, 2019
To the Medical Device Community, From the moment Greenlight Guru was founded, we have taken our lead...
Why You Should Fear Product Liability Attorneys More Than Regulatory Agencies - Featured Image

Why You Should Fear Product Liability Attorneys More Than Regulatory Agencies

By Nick Tippmann on January 25, 2019
Regulatory compliance is critically important. However, some think product liability is just as impo...
Best Practices for Effective Medical Device Design Reviews - Featured Image

Best Practices for Effective Medical Device Design Reviews

By Jon Speer on January 20, 2019
Design Reviews are intended to be checkpoints during medical device product development to ensure th...
Medical Device QMS Changes: How to Manage Changes Regarding EU MDR, IVDR & ISO 13485:2016 - Featured Image

Medical Device QMS Changes: How to Manage Changes Regarding EU MDR, IVDR & ISO 13485:2016

By Rod Beuzeval on January 17, 2019
One thing that seems to be constant in the global medical device industry is change.
Quality Systems Management (QSM) vs. Quality Management System (QMS) - What's The Difference? - Featured Image

Quality Systems Management (QSM) vs. Quality Management System (QMS) - What's The Difference?

By Nick Tippmann on January 16, 2019
Do you know the difference between quality management system (QMS) and quality systems management (Q...
Proactive Quality Systems: FDA Is Prioritizing Them...And You Should Too - Featured Image

Proactive Quality Systems: FDA Is Prioritizing Them...And You Should Too

By Stephanie Christopher, MA, Program Director, Case for Quality & Science of Patient Input on January 13, 2019
FDA’s traditional compliance requirements establish a uniform quality system framework, but do not e...
Aligning True Quality and Compliance with MDDAP - Featured Image

Aligning True Quality and Compliance with MDDAP

By Nick Tippmann on January 9, 2019
What does true quality mean? How does it relate to compliance?
Why Contract Manufacturers Shouldn't Own Your Quality System - Featured Image

Why Contract Manufacturers Shouldn't Own Your Quality System

By Jon Speer on January 7, 2019
Does your medical device company use a third-party or contract manufacturer?
Explaining the Significance of Voluntary Consensus Standards - Featured Image

Explaining the Significance of Voluntary Consensus Standards

By Nick Tippmann on January 2, 2019
What are Voluntary Consensus Standards? Why should you care about them? What role do they play in yo...
FDA Case for Quality: 2018 Comprehensive Review - Featured Image

FDA Case for Quality: 2018 Comprehensive Review

By Jon Speer on January 1, 2019
Top 10 Most Popular Greenlight Guru Posts of 2018 - Featured Image

Top 10 Most Popular Greenlight Guru Posts of 2018

By Nick Tippmann on December 23, 2018
Thank you for helping make 2018 another big and exciting year for Greenlight Guru!
Medical Device Industry Predictions for 2019 - Featured Image

Medical Device Industry Predictions for 2019

By Nick Tippmann on December 19, 2018
It’s time to recap what happened in the medical device industry this year and start to think about w...
Defining Your Medical Device Design Records - Featured Image

Defining Your Medical Device Design Records

By Jon Speer on December 18, 2018
It’s easy to get a bit confused when you consider the records that are required for your medical dev...
6 Predictions for the Medical Device Industry in 2019 (and how you can prepare) - Featured Image

6 Predictions for the Medical Device Industry in 2019 (and how you can prepare)

By Jon Speer on December 9, 2018
Within the past couple of years, we have experienced significant changes in the medical device indus...
FDA Plans to Modernize 510(k) - Is the Sky Falling? - Featured Image

FDA Plans to Modernize 510(k) - Is the Sky Falling?

By Nick Tippmann on December 5, 2018
Have you heard the news? FDA caused quite a stir when it recently announced transformative changes t...
ISO 13485 & MDSAP Deadlines are Fast Approaching (And You Need a Notified Body) - Featured Image

ISO 13485 & MDSAP Deadlines are Fast Approaching (And You Need a Notified Body)

By ECM (Ente Certificazione Macchine) on December 5, 2018
In less than four months, come March 2019, the transitional period for medical device companies to c...
FDA Computer System & Software Validation - What You’ve Known For 20+ Years Is Changing - Featured Image

FDA Computer System & Software Validation - What You’ve Known For 20+ Years Is Changing

By Jon Speer on December 2, 2018
What you’ve known and believed about computer system validation, software validation, and 21 CFR Par...
Understanding the Blurred Lines Between Consumer Tech and MedTech - Featured Image

Understanding the Blurred Lines Between Consumer Tech and MedTech

By Nick Tippmann on November 28, 2018
Did you know that the Apple Watch was recently granted de novo classification requests by the FDA? P...
3 Real World Document Management Horror Stories - Featured Image

3 Real World Document Management Horror Stories

By Jon Speer on November 25, 2018
In the medical device world, it’s not uncommon to get hung up on documentation. “It takes too much t...
Understanding The Differences Between Clearance vs Approval vs Granted - Featured Image

Understanding The Differences Between Clearance vs Approval vs Granted

By Nick Tippmann on November 21, 2018
Are you confused by regulatory terminology? Clearance. Approval. Granted.
Looking to join a fun, fast growing SaaS company? Greenlight Guru is hiring (Again)! - Featured Image

Looking to join a fun, fast growing SaaS company? Greenlight Guru is hiring (Again)!

By Nick Tippmann on November 20, 2018
Are you a smart, talented and ambitious individual looking to be surrounded by other elite performer...
Top 20 Medical Device Venture Capital Firms - Featured Image

Top 20 Medical Device Venture Capital Firms

By Nick Tippmann on November 18, 2018
If you have a great idea for a medical device or have already founded your own medical company, chan...
Streamlining The Device Marketing Authorization Process - Featured Image

Streamlining The Device Marketing Authorization Process

By Nick Tippmann on November 14, 2018
There are a few additional steps to take when it comes to the Medical Device Single Audit Program (M...
Ultimate Guide to ISO 13485 Quality Management System (QMS) for Medical Devices - Featured Image

Ultimate Guide to ISO 13485 Quality Management System (QMS) for Medical Devices

By Jon Speer on November 11, 2018
            TABLE OF CONTENTS What is ISO 13485 Evolution of a Quality Management System ISO 13485 C...
The New Special 510(k): What You Need To Know - Featured Image

The New Special 510(k): What You Need To Know

By Nick Tippmann on November 7, 2018
Have you heard the recent buzz about the FDA’s supposed new Special 510(k) Pilot Program? Is it real...
5 Myths Engineers Believe About Quality (and what is really true) - Featured Image

5 Myths Engineers Believe About Quality (and what is really true)

By Jon Speer on November 4, 2018
A well run medical device company is cross-functional in nature. Engineering, quality, regulatory, m...
What's New With PMAs - Featured Image

What's New With PMAs

By Nick Tippmann on October 31, 2018
How do you feel about pre-market approval (PMA) for Class III medical devices?
Greenlight Guru Announces New Integration with Jira Software - Featured Image

Greenlight Guru Announces New Integration with Jira Software

By Nick Tippmann on October 31, 2018
Quality management software platform for medical device companies now integrates with industry-leadi...
How To Drive Executive Engagement With Quality Systems (and actually get them excited about it) - Featured Image

How To Drive Executive Engagement With Quality Systems (and actually get them excited about it)

By Mark D Proulx, CQA, cSSBB on October 28, 2018
Most Quality people I know hear the same things over and over again. "Management isn't engaged." "Ma...
How to Efficiently Raise Funds for Your Medical Device Company - Featured Image

How to Efficiently Raise Funds for Your Medical Device Company

By Nick Tippmann on October 24, 2018
Are you in the midst of raising funds for a device that you are trying to bring to market? It can be...
Quality vs Compliance Metrics (and what's next for FDA's Case For Quality) - Featured Image

Quality vs Compliance Metrics (and what's next for FDA's Case For Quality)

By Nick Tippmann on October 21, 2018
What is the FDA looking to drive forward in its Case for Quality initiative? 
7 Habits of Highly Effective True Quality Medical Device Professionals - Featured Image

7 Habits of Highly Effective True Quality Medical Device Professionals

By Nick Tippmann on October 17, 2018
What is true quality? How do you achieve it?
15 Reasons Why Medical Device Companies Choose Greenlight Guru - Featured Image

15 Reasons Why Medical Device Companies Choose Greenlight Guru

By Jon Speer on October 14, 2018
The medical device industry has been undergoing a major shift for the past 20 years, and now that sh...
Regulatory Tips & Strategies from a Former FDA Reviewer - Featured Image

Regulatory Tips & Strategies from a Former FDA Reviewer

By Nick Tippmann on October 10, 2018
What are some recent trends and observations in the medical device industry regarding regulatory aff...
FDA Aligning to ISO 13485:2016 (and Why It Matters) - Featured Image

FDA Aligning to ISO 13485:2016 (and Why It Matters)

By Jon Speer on October 7, 2018
Earlier this year, the FDA announced their intentions to change the US’s current medical device regu...
Questions to Ask Before Hiring Your QA/RA Consultant - Featured Image

Questions to Ask Before Hiring Your QA/RA Consultant

By Nick Tippmann on October 3, 2018
Do you work with regulatory consultants to implement a quality system or 510(k), or perform other ta...
What it Means to be Focused on Quality vs. Compliance - Featured Image

What it Means to be Focused on Quality vs. Compliance

By Jon Speer on September 30, 2018
Would you describe your company as quality focused?
What You Need to Know About The FDA CDRH Experiential Learning Program - Featured Image

What You Need to Know About The FDA CDRH Experiential Learning Program

By Nick Tippmann on September 26, 2018
FDA has a new program called, The Experiential Learning Program, which involves CDRH going to medica...
What are the Regulatory Expectations for Software as a Medical Device (SaMD)? - Featured Image

What are the Regulatory Expectations for Software as a Medical Device (SaMD)?

By Jon Speer on September 23, 2018
In today’s highly connected world, medical devices often include state-of-the-art software, or, the ...
Latest Updates on CDRH Standards Program and IEC 60601 - Featured Image

Latest Updates on CDRH Standards Program and IEC 60601

By Nick Tippmann on September 19, 2018
Medical device standards seem to change and evolve all the time. Is it impossible to keep up with th...
The Importance of Good Document Management (And How To Do It) - Featured Image

The Importance of Good Document Management (And How To Do It)

By Jon Speer on September 16, 2018
The long-term success of medical device companies depends on the strength of their foundation. Good ...
Why the FDA Case for Quality Matters - Featured Image

Why the FDA Case for Quality Matters

By Jon Speer on September 13, 2018
When I first learned about the FDA’s Case for Quality initiative, I immediately wanted to learn more...
15 Habits of Highly Effective Regulatory Professionals - Featured Image

15 Habits of Highly Effective Regulatory Professionals

By Nick Tippmann on September 12, 2018
Quality and regulatory professionals in the medical device industry have to deal with a lot. In this...
21 CFR Part 11: A Complete Guide - Featured Image

21 CFR Part 11: A Complete Guide

By Jon Speer on September 10, 2018
Medical device companies that wish to sell their devices in the US and EU must implement a quality m...
Greenlight Guru Announces Advanced Document Management - Featured Image

Greenlight Guru Announces Advanced Document Management

By Nick Tippmann on September 5, 2018
Functionality enhances security while maintaining visibility and transparency in medical device qual...
How to Embrace Risk for Safer Devices - Featured Image

How to Embrace Risk for Safer Devices

By Nick Tippmann on September 5, 2018
No matter what you are working on, there are risks involved. Product development is complicated.
Scaling Regulatory and Quality with Your Company - Featured Image

Scaling Regulatory and Quality with Your Company

By Jon Speer on September 2, 2018
  Have you thought about your systems and processes related to regulatory and quality standards?
What you need to know About FDA’s Progressive Programs - Featured Image

What you need to know About FDA’s Progressive Programs

By Nick Tippmann on August 29, 2018
Are you familiar with FDA’s progressive programs for medical device companies? Do you know about Exp...
FDA Case for Quality Program: What, Why and How? - Featured Image

FDA Case for Quality Program: What, Why and How?

By Jon Speer on August 26, 2018
We recently launched a webinar series alongside the FDA, looking at its Case for Quality Program.
What Are the Regulatory Expectations for Software as a Medical Device (SaMD)? - Featured Image

What Are the Regulatory Expectations for Software as a Medical Device (SaMD)?

By Nick Tippmann on August 22, 2018
These days, medical devices often include software or are standalone software. So, software as a med...
AI Explainability: What That Means and Why it Matters in Healthcare - Featured Image

AI Explainability: What That Means and Why it Matters in Healthcare

By Jon Speer on August 19, 2018
Is AI a topic we should be focused on in the medical device industry? Artificial Intelligence has ta...
The Bleeding Edge: Lessons Learned for the Medical Device Industry - Featured Image

The Bleeding Edge: Lessons Learned for the Medical Device Industry

By Nick Tippmann on August 17, 2018
Sometimes, do things make you go, “Hhhmmmm…” Jon Speer recently watched a documentary about the medi...
AI Explainability: What that Means and Why it Matters in the Medical Device Industry - Featured Image

AI Explainability: What that Means and Why it Matters in the Medical Device Industry

By Nick Tippmann on August 14, 2018
Is artificial intelligence (AI) a topic that should be focused on in the medical device industry?
Why Your Company Needs an Electronic Quality Management System - Featured Image

Why Your Company Needs an Electronic Quality Management System

By Jon Speer on August 12, 2018
It’s time to face facts: a paper-based quality management system is no longer an option. 
How Human Factors Impact Your Medical Device - Featured Image

How Human Factors Impact Your Medical Device

By Nick Tippmann on August 8, 2018
Human factors can be a tricky topic that creates confusion, especially when it comes to medical devi...
Medical Device Companies - Top 100 in 2018 (Free Chart) - Featured Image

Medical Device Companies - Top 100 in 2018 (Free Chart)

By Nick Tippmann on August 5, 2018
Have you ever wondered about the biggest medical device companies in the world? Maybe you're looking...
How to Think About Quality and Regulatory as Your Company Scales - Featured Image

How to Think About Quality and Regulatory as Your Company Scales

By Nick Tippmann on August 1, 2018
As companies transition from being a start-up or small company to a more established business and br...
Challenging “Conventional Wisdom” in Medtech R and D - Featured Image

Challenging “Conventional Wisdom” in Medtech R and D

By Jon Speer on July 29, 2018
The idea of “research versus development” can be highly controversial and much-debated among medical...
How to Design for Compliance with IEC60601 - Featured Image

How to Design for Compliance with IEC60601

By Nick Tippmann on July 25, 2018
Have you ever designed a medical device that has electrical components? Was it frustrating to go thr...
FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare Yours - Featured Image

FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare Yours

By Jesseca Lyons on July 20, 2018
What's this guide all about anyways? Feeling a little lost as you start to compile your first 510(k)...
FDA Proposes Allowing Medical Device Makers to Summarize Malfunctions: What does that Mean for You? - Featured Image

FDA Proposes Allowing Medical Device Makers to Summarize Malfunctions: What does that Mean for You?

By Nick Tippmann on July 18, 2018
The FDA announced a new proposal regarding the bundling of device malfunctions when Medical Device R...
A Guide to Bridging User Needs Into Design Requirements - Featured Image

A Guide to Bridging User Needs Into Design Requirements

By Jon Speer on July 16, 2018
“The answers are only as good as the questions we ask!”
Why There is a Need for Multi-Level Design Controls - Featured Image

Why There is a Need for Multi-Level Design Controls

By Nick Tippmann on July 12, 2018
We’ve added an exciting new update to our platform recently. The ability to manage multi-level desig...
How to Use the Abbreviated FDA 510(k) Pathway to Your Advantage - Featured Image

How to Use the Abbreviated FDA 510(k) Pathway to Your Advantage

By Nick Tippmann on July 12, 2018
Do you know how to use the FDA’s abbreviated 510(k)? Since only 2 percent of 510(k)s have gone the a...
How a Partnership with Greenlight Guru Helped Rook Quality Systems Grow 5X in Two Years - Featured Image

How a Partnership with Greenlight Guru Helped Rook Quality Systems Grow 5X in Two Years

By Connor Remaley on July 10, 2018
Have you ever wondered what partnering with Greenlight Guru could mean for your business? We have a ...
Ready to Submit Your FDA 510(k)? But Wait, There's No Human Factors! - Featured Image

Ready to Submit Your FDA 510(k)? But Wait, There's No Human Factors!

By Mary Beth Privitera, PhD, FIDSA on June 18, 2018
If there’s no use risk, then no problem! That's what most directives indicate, however, users are un...
What Medical Device Developers Should Know About Human Factors - Featured Image

What Medical Device Developers Should Know About Human Factors

By Jon Speer on June 11, 2018
Human factors can be a topic rife with confusion for medical device developers. What do they mean? W...
Tips for Running Effective Internal Quality Audits - Featured Image

Tips for Running Effective Internal Quality Audits

By Jon Speer on June 4, 2018
How did your last internal quality audit go? Internal audits can be a bit of a scramble in some comp...
How Priority Designs Used Greenlight Guru to Gain ISO 13485:2016 Certification - Featured Image

How Priority Designs Used Greenlight Guru to Gain ISO 13485:2016 Certification

By Nick Tippmann on May 25, 2018
We have many different types of companies using Greenlight Guru to help them create a compliant qual...
How SOLIUS Went from Scratch to an eQMS and ISO 13485:2016 Certification - Featured Image

How SOLIUS Went from Scratch to an eQMS and ISO 13485:2016 Certification

By Nick Tippmann on May 25, 2018
It can be challenging for small companies to navigate the medical device regulatory pathways, especi...
Creating an Effective Quality Culture that Benefits Your Patients - Featured Image

Creating an Effective Quality Culture that Benefits Your Patients

By Nick Tippmann on May 20, 2018
We all want medical devices that improve the quality of life for patients, right?
Debunking Premarket Approval (PMA) Myths (And Why the PMA Path May Not Be as Scary as You Think) - Featured Image

Debunking Premarket Approval (PMA) Myths (And Why the PMA Path May Not Be as Scary as You Think)

By Nick Tippmann on May 15, 2018
When developing a new medical device, do you try to figure out the fastest and simplest way to get y...
Sneak Peek Into the ISO 14971 Revision Process (From a Member of the Standard's Working Group, JWG1) - Featured Image

Sneak Peek Into the ISO 14971 Revision Process (From a Member of the Standard's Working Group, JWG1)

By Edwin Bills, ASQ Fellow, RAC on May 14, 2018
The ISO Technical Committee TC 210 Joint Working Group 1 (JWG1) is a committee that reports to not o...
Tips, Tricks & Best Practices for Complying with ISO 13485:2016 - Featured Image

Tips, Tricks & Best Practices for Complying with ISO 13485:2016

By Nick Tippmann on May 8, 2018
When it comes to ISO 13485:2016, are you scrambling to meet requirements? Are you trying to figure o...
Greenlight Guru Announces Multi-Level Design Control Software - Featured Image

Greenlight Guru Announces Multi-Level Design Control Software

By Nick Tippmann on May 7, 2018
Functionality enables visibility into multiple workspaces, holistic view of design components and a ...
The Ultimate Guide To Design Controls For Medical Device Companies - Featured Image

The Ultimate Guide To Design Controls For Medical Device Companies

By Jon Speer on May 7, 2018
FDA Warning Letters and Form 483 Observations - What’s the Difference? - Featured Image

FDA Warning Letters and Form 483 Observations - What’s the Difference?

By Jon Speer on April 30, 2018
If you’re a medical device company manufacturing Class II or Class III devices, you can expect to ha...
Helping to Prepare Biomedical Engineers Entering the Workforce - Featured Image

Helping to Prepare Biomedical Engineers Entering the Workforce

By Nick Tippmann on April 24, 2018
Students offer hope for our future. They will be developing products that can save our lives, or at ...
Competitive Regulatory Strategy vs. Regular Regulatory Strategy - Featured Image

Competitive Regulatory Strategy vs. Regular Regulatory Strategy

By Jon Speer on April 23, 2018
Every medical device developer would like to take the fastest path to market, right?
How to Ensure Your Quality Management System is Effective and Benefits Patients - Featured Image

How to Ensure Your Quality Management System is Effective and Benefits Patients

By Nick Tippmann on April 19, 2018
When it comes to quality management compliance, would you consider yourself a box checker or a true ...
Timeline to ISO 13485:2016 (And Why You Need to Act Today) - Featured Image

Timeline to ISO 13485:2016 (And Why You Need to Act Today)

By Jon Speer on April 15, 2018
To be blunt, if your company has put off doing anything about ISO 13485:2016, you need to act immedi...
7 Problems with a Paper-Based Design History File (And How to Avoid Them) - Featured Image

7 Problems with a Paper-Based Design History File (And How to Avoid Them)

By Jon Speer on April 9, 2018
If you’re using a paper-based system to manage your design history file (DHF), it can raise several ...
What You Need to Know About Risk Management and Using Post-Market Data - Featured Image

What You Need to Know About Risk Management and Using Post-Market Data

By Jon Speer on March 26, 2018
The aim for any medical device company is always to ensure that the devices they make are safe and e...
CAPA Process Mistakes You Want to Avoid - Featured Image

CAPA Process Mistakes You Want to Avoid

By Nick Tippmann on March 21, 2018
What are the most common problems with the CAPA process?
Understanding the New Requirements for QMS Software Validation in ISO 13485:2016 - Featured Image

Understanding the New Requirements for QMS Software Validation in ISO 13485:2016

By Kyle Rose on March 19, 2018
As I am sure many of you know, the ISO 13485 standard was updated in 2016, which means the time to t...
How to Determine the Operational Quality of a Quality System Using a Performance Assessment - Featured Image

How to Determine the Operational Quality of a Quality System Using a Performance Assessment

By Nick Tippmann on March 14, 2018
Are you ready for audits? ISO? FDA? Is your quality management system working the way you want it to...
Quality Management Audit or Assessment? - Featured Image

Quality Management Audit or Assessment?

By Larry Mager on March 12, 2018
What's the difference between the two? Plenty!
Understanding the 5 Phases of Medical Device Development - Featured Image

Understanding the 5 Phases of Medical Device Development

By Adnan Ashfaq on March 5, 2018
Do you have a medical device to launch? Well I have good news for you and I have bad news for you.
What Substantial Equivalence Means as It Applies to 510(k)'s & Why It's Important - Featured Image

What Substantial Equivalence Means as It Applies to 510(k)'s & Why It's Important

By Nick Tippmann on February 21, 2018
Do you have a firm grasp and understanding of what substantial equivalence means in regards to the 5...
CAPA Process - Step-by-Step Instructions [Infographic] - Featured Image

CAPA Process - Step-by-Step Instructions [Infographic]

By Jon Speer on February 20, 2018
CAPA is an area that we talk about often, mainly because it’s still such a big issue for medical dev...
4 Tips for Handling Nonconformances - Featured Image

4 Tips for Handling Nonconformances

By Jon Speer on February 12, 2018
The safety and efficacy of your product rides heavily on the quality of the components that make it ...
How to Structure Your Internal Audit Program for the New Year (Plus 4 Tips) - Featured Image

How to Structure Your Internal Audit Program for the New Year (Plus 4 Tips)

By Jon Speer on January 21, 2018
As your company heads back from holiday breaks, what’s happening into the New Year?
Ultimate List of Medical Device Incubators and Accelerators (50+) - Featured Image

Ultimate List of Medical Device Incubators and Accelerators (50+)

By Nick Tippmann on January 12, 2018
Medical startups around the United States face many of the same challenges when it comes to achievin...
Evaluating FDA’s “New” Proposed Fast-Track Alternative Approach to the 510(k) Pathway - Featured Image

Evaluating FDA’s “New” Proposed Fast-Track Alternative Approach to the 510(k) Pathway

By Nick Tippmann on January 10, 2018
This past month, the FDA drafted a guidance on a quick path to approval as an alternative to the 510...
5 Predictions for the Medical Device Industry in 2018 (And How You Can Prepare) - Featured Image

5 Predictions for the Medical Device Industry in 2018 (And How You Can Prepare)

By Jon Speer on January 8, 2018
There is an old saying that the only thing that is constant in life is change. For the medical devic...
Top 10 Most Popular Greenlight Guru Medical Devices Posts of 2017 - Featured Image

Top 10 Most Popular Greenlight Guru Medical Devices Posts of 2017

By Nick Tippmann on December 25, 2017
Thanks for helping make 2017 another big and exciting year for Greenlight Guru filled with tremendou...
An Overview of What Medical Device Developers Need to Know About Human Factors - Featured Image

An Overview of What Medical Device Developers Need to Know About Human Factors

By Nick Tippmann on December 20, 2017
  The topic of human factors can be confusing: How does it relate to design factors and risk? Why is...
15 Steps to Getting Approval for IEC 60601-1 - Featured Image

15 Steps to Getting Approval for IEC 60601-1

By Jon Speer on December 18, 2017
  Does your company have approval for IEC 60601-1? If you produce medical electrical equipment (MEE)...
How to Integrate Complaint Handling and Risk Management - Featured Image

How to Integrate Complaint Handling and Risk Management

By Jon Speer on December 5, 2017
Did you know that complaint handling continues to be a big reason medical device companies receive 4...
Challenges with Applying Risk Management Throughout the Manufacturing Process - Featured Image

Challenges with Applying Risk Management Throughout the Manufacturing Process

By Nick Tippmann on November 29, 2017
Today we’re going to be taking the topic of risk management to the next level. We are talking to Jim...
How to Streamline the Customer Complaint Handling Process - Featured Image

How to Streamline the Customer Complaint Handling Process

By Jon Speer on November 27, 2017
It can be quite nerve-wracking the very first time your medical device company receives a complaint ...
13 Steps to Creating a Risk-Based CAPA Process - Featured Image

13 Steps to Creating a Risk-Based CAPA Process

By Nick Tippmann on November 20, 2017
What does it mean to create a risk-based CAPA process? How should companies go about it?
Common Mistakes That Can Tank Your FDA 510(k) Submission - Featured Image

Common Mistakes That Can Tank Your FDA 510(k) Submission

By Nick Tippmann on November 16, 2017
Do you know the percentage of 510(k)s that are rejected by the FDA the first time? Shockingly, it’s ...
What is Software as a Medical Device (SaMD)? - Featured Image

What is Software as a Medical Device (SaMD)?

By Jon Speer on November 13, 2017
Medical devices are a big business covering a wide range of modalities and applications. To ensure t...
Understanding How to Use Real-World Evidence for Medical Device Regulatory Decisions - Featured Image

Understanding How to Use Real-World Evidence for Medical Device Regulatory Decisions

By Nick Tippmann on November 8, 2017
The topic of Real-World Evidence is generating a lot of discussion lately, especially after the draf...
Here Are the 4 Types of FDA Inspections You Need to Understand - Featured Image

Here Are the 4 Types of FDA Inspections You Need to Understand

By Jon Speer on November 6, 2017
Every medical device manufacturer knows that, at some point, they should expect the FDA to arrive to...
Greenlight Guru Extends Platform with New Product, Grow, to Streamline PostMarket Quality Processes - Featured Image

Greenlight Guru Extends Platform with New Product, Grow, to Streamline PostMarket Quality Processes

By Nick Tippmann on October 30, 2017
The only eQMS specifically for medical device will enable companies to move beyond baseline complian...
Ultimate Guide to Corrective and Preventive Action (CAPA) for Medical Devices - Featured Image

Ultimate Guide to Corrective and Preventive Action (CAPA) for Medical Devices

By Jon Speer on October 27, 2017
  What Is This CAPA Guide About? As an experienced medical device professional who has worked with d...
How to Prepare for the Medical Device Single Audit Program (MDSAP) - Featured Image

How to Prepare for the Medical Device Single Audit Program (MDSAP)

By Jon Speer on October 23, 2017
How is your understanding of the Medical Device Single Audit Program (MDSAP)?
Lessons to Be Learned from Recent FDA Inspections - Featured Image

Lessons to Be Learned from Recent FDA Inspections

By Nick Tippmann on October 18, 2017
Something that you might find surprising is the number of medical device companies that are simply n...
How MEDDEV 2.7.1 Rev 4 Affects Medical Device Manufacturers - Featured Image

How MEDDEV 2.7.1 Rev 4 Affects Medical Device Manufacturers

By Jon Speer on October 16, 2017
Up until the latest revision of MEDDEV 2.7.1 was published on June 29th, 2016, clinical data provide...
Why the 510(k) Process Is So Stressful & How You Can Help Streamline It - Featured Image

Why the 510(k) Process Is So Stressful & How You Can Help Streamline It

By Jon Speer on October 11, 2017
  My guest today is Juan Carlos Serna, the co-founder of Right Submission. If you have been in the m...
Standard Conformity or Regulatory Compliance? Distinguishing the Two - Featured Image

Standard Conformity or Regulatory Compliance? Distinguishing the Two

By Jon Speer on October 9, 2017
So, you have a certificate hanging on your wall showing that you’ve passed an audit and conform with...
What Does a Risk-Based QMS Mean? - Featured Image

What Does a Risk-Based QMS Mean?

By Jon Speer on October 1, 2017
What exactly is a risk-based QMS?
What You Need to Know About the 510(k) Submission Process - Featured Image

What You Need to Know About the 510(k) Submission Process

By Jon Speer on September 24, 2017
Have you ever been through the experience of having the FDA refuse to accept your 510(k) submission?...
FDA Inspections and ISO Audits: What is the Difference? - Featured Image

FDA Inspections and ISO Audits: What is the Difference?

By Jon Speer on September 18, 2017
It’s every medical device manufacturer's favorite time…the arrival of an FDA inspector or ISO audito...
How to Switch to eQMS Software When You're Just Using Paper - Featured Image

How to Switch to eQMS Software When You're Just Using Paper

By Jon Speer on September 11, 2017
How reliable is your paper-based quality management system? This situation plays out in medical devi...
Why You Need To Stop Treating Risk Management & Design Controls as Checkbox Activities - Featured Image

Why You Need To Stop Treating Risk Management & Design Controls as Checkbox Activities

By Jon Speer on September 4, 2017
Understanding the relationship between product risk management and design controls is critical to th...
How Competitive Regulatory Strategy Differs from Regular Regulatory Strategy (And How to Use It to Your Advantage) - Featured Image

How Competitive Regulatory Strategy Differs from Regular Regulatory Strategy (And How to Use It to Your Advantage)

By Nick Tippmann on August 30, 2017
Have you ever considered the pros and cons of a PMA vs a 501(k)? Some of the considerations you must...
The Do’s and Don’ts of an FDA Inspection - Featured Image

The Do’s and Don’ts of an FDA Inspection

By Jon Speer on August 28, 2017
FDA has arrived at your premises…
How to Translate Voice of Customer into User Needs - Featured Image

How to Translate Voice of Customer into User Needs

By Nichole Leahy-Glass on August 21, 2017
How well do you do at capturing “voice of customer” and translating into user needs?
Comparing FDA Submission Types: 510(k) vs. De Novo vs. 513(g) vs. Pre-Submission - Featured Image

Comparing FDA Submission Types: 510(k) vs. De Novo vs. 513(g) vs. Pre-Submission

By Nick Tippmann on August 18, 2017
It can be confusing to know which submission type is the correct one for your particular development...
How to Retroactively Create Design Controls and DHF (Even Though You Should Never Let This Happen) - Featured Image

How to Retroactively Create Design Controls and DHF (Even Though You Should Never Let This Happen)

By Jon Speer on August 13, 2017
So, you haven’t completed your design controls or design history file (DHF)...
7 Common Mistakes That Can Delay Your FDA 510(k) Clearance - Featured Image

7 Common Mistakes That Can Delay Your FDA 510(k) Clearance

By Jon Speer on August 8, 2017
  The 510(k) clearance process is often met with a mix of trepidation and anticipation by medical de...
How Process Excellence Leads to Product Excellence - Featured Image

How Process Excellence Leads to Product Excellence

By Nick Tippmann on August 2, 2017
Today, we are talking to Mike Fisher, who is the director of product development at the Global Cente...
Debunking 8 Commonly Held CAPA Myths - Featured Image

Debunking 8 Commonly Held CAPA Myths

By Jon Speer on July 30, 2017
CAPA (Corrective and Preventive Action) is a source of ongoing issues within medical device companie...
How to Prepare Your Design History File (DHF) for an FDA Inspection - Featured Image

How to Prepare Your Design History File (DHF) for an FDA Inspection

By Jon Speer on July 23, 2017
  So, the FDA is coming to inspect your medical device company.
Understanding FDA’s Proposed Conformity Assessment Pilot Program - Featured Image

Understanding FDA’s Proposed Conformity Assessment Pilot Program

By Nick Tippmann on July 21, 2017
Today on the Global Medical Device Podcast, we’ll be talking to Mike Drues, who is a frequent guest ...
13 Common Pitfalls to Avoid During Medical Device Product Development - Featured Image

13 Common Pitfalls to Avoid During Medical Device Product Development

By Jon Speer on July 9, 2017
Are you falling into some of the common traps that surround medical device product development?
Design Validation vs. Clinical Evaluation: What’s the Difference? - Featured Image

Design Validation vs. Clinical Evaluation: What’s the Difference?

By Jon Speer on June 30, 2017
How confident are you when it comes to design validation? Does this always involve clinical evaluati...
5 Tips for Conducting Medical Device Management Reviews - Featured Image

5 Tips for Conducting Medical Device Management Reviews

By Jon Speer on June 23, 2017
When was your last company management review? If you’re left scratching your head, it either may not...
How to Define and Decode Your Design Inputs and Design Outputs - Featured Image

How to Define and Decode Your Design Inputs and Design Outputs

By Jon Speer on June 18, 2017
We’re looking at a topic that confuses a lot of medical device developers.
Technical File vs. 510(k) vs. Design History File: What Medical Device Developers Should Know - Featured Image

Technical File vs. 510(k) vs. Design History File: What Medical Device Developers Should Know

By Jon Speer on June 9, 2017
Sometimes it feels like you need to know an entirely new language to work in the medical device fiel...
How To Prepare for an FDA Inspection (Plus 5 Tips) - Featured Image

How To Prepare for an FDA Inspection (Plus 5 Tips)

By Jon Speer on June 5, 2017
Over the past several years, FDA has been more aggressive and active in performing medical device co...
Understanding the Difference Between a General Wellness Device and a Regulated Medical Device - Featured Image

Understanding the Difference Between a General Wellness Device and a Regulated Medical Device

By Nick Tippmann on May 31, 2017
Today Jon Speer and Mike Drues are going to be discussing general wellness devices. Mike is the pres...
Understanding the Connection Between Complaints, CAPAs, and MDRs - Featured Image

Understanding the Connection Between Complaints, CAPAs, and MDRs

By Nick Tippmann on May 24, 2017
Today we are going to talk about the connection between complaints, CAPAs, and MDRs. They are all in...
When Design Inputs Go Wrong + Design Your Label Like You Design Your Device - Featured Image

When Design Inputs Go Wrong + Design Your Label Like You Design Your Device

By Nick Tippmann on May 17, 2017
Today’s guest is Mike Drues, the president of Vascular Sciences and a world-renowned expert on all t...
EU MDR and IVDR Are Live – Here Are Some Important Items You Should Know! - Featured Image

EU MDR and IVDR Are Live – Here Are Some Important Items You Should Know!

By Dr. Gert W. Bos on May 16, 2017
After almost 10 years of careful deliberations, the new EU regulations on medical devices finally ha...
Clinical Evaluation Reports — Things You Should Know About the MEDDEV 2.7/1 Revision 4 - Featured Image

Clinical Evaluation Reports — Things You Should Know About the MEDDEV 2.7/1 Revision 4

By Florian Tolkmitt on May 11, 2017
European legislation requires medical device manufacturers to perform a conformity assessment of the...
Better Root Cause Analysis for Safer, More Effective Medical Devices - Featured Image

Better Root Cause Analysis for Safer, More Effective Medical Devices

By Jon Speer on May 8, 2017
Have you really figured out the root cause of any issues found in your medical device company? Root ...
The Intersection of Medical Device Usability and Risk Management - Featured Image

The Intersection of Medical Device Usability and Risk Management

By Nick Tippmann on April 27, 2017
Today we’re going to be talking to our good friend Mike Drues from Vascular Sciences about the inter...
CAPA: When to Take Corrective Action or Preventive Action? - Featured Image

CAPA: When to Take Corrective Action or Preventive Action?

By Jon Speer on April 25, 2017
How many of you can confidently initiate a CAPA and know exactly how and what to do and the process ...
What is a “Quality Data Source” for your CAPA Process? - Featured Image

What is a “Quality Data Source” for your CAPA Process?

By Jon Speer on April 17, 2017
There’s a phrase that the FDA states in their policies around CAPA, which elicits a few questions. T...
Tips for Conducting Better Root Cause Analysis for Medical Device Companies - Featured Image

Tips for Conducting Better Root Cause Analysis for Medical Device Companies

By Jon Speer on April 10, 2017
At some point, every medical device development company will encounter an issue that requires an inv...
This is a What … Unforeseen Pitfalls when Classifying a Medical Device - Featured Image

This is a What … Unforeseen Pitfalls when Classifying a Medical Device

By John F. Johnson III on April 7, 2017
“This is a what” is not only a torturous summer-camp game, but an essential question when working to...
How FDA Interacts with Medical Devices When They Are Imported Into the US - Featured Image

How FDA Interacts with Medical Devices When They Are Imported Into the US

By Nick Tippmann on April 5, 2017
Does your medical device company import components, parts, or materials used in the development or m...
What Should Really Trigger a CAPA? - Featured Image

What Should Really Trigger a CAPA?

By Jon Speer on April 4, 2017
Over years of working with medical device companies, we’ve found that there is a particular area tha...
How SimplicityMD Is Leveraging Technology Plus a Lean Approach to Help Get Their Devices to Market Faster - Featured Image

How SimplicityMD Is Leveraging Technology Plus a Lean Approach to Help Get Their Devices to Market Faster

By Nick Tippmann on March 29, 2017
In today’s episode we continue our series on new breed medical device company stories. We talk with ...
EN ISO 14971:2012 Risk Assessment Explained in 5 Minutes… Using the Grossest Example Ever? - Featured Image

EN ISO 14971:2012 Risk Assessment Explained in 5 Minutes… Using the Grossest Example Ever?

By David Amor on March 27, 2017
This post was originally published by David Amor on LinkedIn and reposted here with the author's per...
Fundamentals of Supplier Management for Medical Device Companies - Featured Image

Fundamentals of Supplier Management for Medical Device Companies

By Jesseca Lyons on March 19, 2017
As a manufacturer of medical devices, it is your responsibility to be on top of the entire system th...
An Overview of What Device Makers Need to Know About CAPA - Featured Image

An Overview of What Device Makers Need to Know About CAPA

By Nick Tippmann on March 15, 2017
Today we will be talking about a topic that seems to be an area of continual concern and, in some ca...
Key Actions for Effective Customer Complaint Handling - Featured Image

Key Actions for Effective Customer Complaint Handling

By Jon Speer on March 14, 2017
Let's say, your medical device business has received a complaint from a customer.
5 Tips for Medical Device Engineers on FDA Design Controls - Featured Image

5 Tips for Medical Device Engineers on FDA Design Controls

By Jon Speer on March 6, 2017
If you’re in the medical device industry, you may think that design controls are a confusing imposit...
How Surgical Innovation Associates Found the Benefit of Quality Beyond Just Compliance - Featured Image

How Surgical Innovation Associates Found the Benefit of Quality Beyond Just Compliance

By Nick Tippmann on March 2, 2017
At greenlight.guru, we would like to continue our series on the new breed of medical device companie...
9 Keys to Enacting CAPA for Medical Devices Following Your Internal Audit - Featured Image

9 Keys to Enacting CAPA for Medical Devices Following Your Internal Audit

By Jon Speer on February 28, 2017
Most of us really don’t get excited by the prospect of any kind of audit. The procedures, the paperw...
How to Speed up your Product Development Process - Featured Image

How to Speed up your Product Development Process

By Jon Speer on February 20, 2017
Speed to market is one of the major challenges for medical device companies; how can you expedite th...
Significant Risk vs. Nonsignificant Risk Devices - What's the Difference? - Featured Image

Significant Risk vs. Nonsignificant Risk Devices - What's the Difference?

By Nick Tippmann on February 14, 2017
Do you understand the difference between significant risk and nonsignificant risk when it comes to t...
4 Key Compliance Issues for Medical Device Companies - Featured Image

4 Key Compliance Issues for Medical Device Companies

By Jon Speer on February 11, 2017
The goal for most creators of new medical devices is to be able to get them to market as quickly as ...
What is CAPA in the Medical Device Industry? - Featured Image

What is CAPA in the Medical Device Industry?

By Jon Speer on February 6, 2017
If you’re relatively new to the medical device development industry, you will have worked out fairly...
Key Challenges for Risk Management in Medical Device Development - Featured Image

Key Challenges for Risk Management in Medical Device Development

By Jon Speer on January 29, 2017
If you’re in the business of developing medical devices, then risk and risk management become terms ...
What Devicemakers Need to Know About Medical Device Reporting (MDR) - Featured Image

What Devicemakers Need to Know About Medical Device Reporting (MDR)

By Nick Tippmann on January 25, 2017
Medical device reporting, or MDR: what is it? What isn’t it? Why is it important?
How Phagenesis Is Developing a Treatment for Dysphagia with Rebecca Sheridan - Featured Image

How Phagenesis Is Developing a Treatment for Dysphagia with Rebecca Sheridan

By Nick Tippmann on January 12, 2017
What if regulatory affairs were not only viewed as a necessary burden, but actually help a medical d...
5 Things the Medical Device Industry Should Expect in 2017 (And How You Can Prepare) - Featured Image

5 Things the Medical Device Industry Should Expect in 2017 (And How You Can Prepare)

By Jon Speer on January 9, 2017
What should the medical device industry expect in 2017? Great question. I’d like to share some of my...
A Review of the Most Important Medical Device Industry Topics in 2016 - Featured Image

A Review of the Most Important Medical Device Industry Topics in 2016

By Jon Speer on January 3, 2017
2016 was a very active and monumental year for the medical device industry. There were several impor...
2016 Medical Device Regulatory Trends Year in Review - Featured Image

2016 Medical Device Regulatory Trends Year in Review

By Nick Tippmann on December 29, 2016
We’re in the last days of 2016, and it’s a good time to look back as we plan for the future. On toda...
Top 10 Most Popular Medical Device Articles of 2016 (Plus Top 5 Free Webinars and Podcasts) - Featured Image

Top 10 Most Popular Medical Device Articles of 2016 (Plus Top 5 Free Webinars and Podcasts)

By Nick Tippmann on December 14, 2016
Thanks for helping make 2016 another big and exciting year for Greenlight Guru filled with growth! W...
Using the Bucket Method for Medical Device Risk Management - Featured Image

Using the Bucket Method for Medical Device Risk Management

By Nick Tippmann on December 6, 2016
Risk management: It’s a topic that needs to be navigated carefully by medical device companies. It’s...
Tips for Success When It Comes to IEC 60601 with Leo Eisner - Featured Image

Tips for Success When It Comes to IEC 60601 with Leo Eisner

By Nick Tippmann on November 22, 2016
  IEC 60601 is a challenge for companies that are developing electronic medical devices. It’s wise t...
The Business Case for Integrated Design Controls - Featured Image

The Business Case for Integrated Design Controls

By Jon Speer on November 20, 2016
What role do you believe design controls play in the growth and stability of your company? I suspect...
How a New Breed of Medical Device Companies Is Leveraging Technology to Get More Done with Less Resources - Featured Image

How a New Breed of Medical Device Companies Is Leveraging Technology to Get More Done with Less Resources

By Nick Tippmann on November 8, 2016
Zebra Medical Technologies is part of a new breed of medical device companies. They understand the r...
Medical Device Risk – ISO 14971 Gets It Right - Featured Image

Medical Device Risk – ISO 14971 Gets It Right

By William Storage on November 7, 2016
Editor's note: This is a guest post authored by William Storage, VP LiveSky Inc., Visiting Scholar, ...
Understanding the New FDA Guidance on Changes to a 510(k) - Featured Image

Understanding the New FDA Guidance on Changes to a 510(k)

By Nick Tippmann on October 26, 2016
What happens you need to make a change to a device that’s been cleared via 510(k)?
An Introduction to FDA 21 CFR Part 11 - Featured Image

An Introduction to FDA 21 CFR Part 11

By Jon Speer on October 25, 2016
Every week that goes by, I talk to several medical device companies all over the world who have esta...
What Devicemakers Need to Know about the FDA Pre-submission Process (Part Two) - Featured Image

What Devicemakers Need to Know about the FDA Pre-submission Process (Part Two)

By Nick Tippmann on October 19, 2016
FDA Pre-submissions: They're a hot, timely topic.
Preparing for the Changes to the EU Medical Device and In-ViTRo Diagnostics Regulations - Featured Image

Preparing for the Changes to the EU Medical Device and In-ViTRo Diagnostics Regulations

By Nick Tippmann on October 12, 2016
Agreement was reached on the eagerly awaited new EU Medical Device Regulations (MDR) and In-Vitro Di...
ISO 13485:2016 vs. ISO 13485:2003 vs. FDA 21 CFR Part 820 - Featured Image

ISO 13485:2016 vs. ISO 13485:2003 vs. FDA 21 CFR Part 820

By Jon Speer on October 10, 2016
The publication and release of ISO 13485:2016 earlier this year is a significant movement for the me...
Tips for Avoiding Problems with the First-In-Human Study Process - Featured Image

Tips for Avoiding Problems with the First-In-Human Study Process

By Nick Tippmann on October 4, 2016
When it comes to moving from the conceptual phase of developing a medical device and actually doing ...
What's with the Rush to First-In-Human Studies? - Featured Image

What's with the Rush to First-In-Human Studies?

By Jon Speer on September 26, 2016
Any medical device initially starts with an idea — a problem to solve, with the hope of positively i...
Tips & Pointers for Effective Internal Quality Audits with Kyle Rose - Featured Image

Tips & Pointers for Effective Internal Quality Audits with Kyle Rose

By Nick Tippmann on September 12, 2016
Internal audits might be inconvenient and a bit nerve-wracking, but they’re also educational.
How to Properly Use the FDA Pre-Submission Process and Why It's So Important - Featured Image

How to Properly Use the FDA Pre-Submission Process and Why It's So Important

By Nick Tippmann on August 31, 2016
In order to get your medical device to market, you will need to know about pre-submissions and the p...
Why Poor Design Controls Mean More Medical Device Complaints - Featured Image

Why Poor Design Controls Mean More Medical Device Complaints

By Jon Speer on August 29, 2016
I’ll venture a guess that you want to get your medical device to market ASAP!
Greenlight Guru Invited to Host Two Workshop Sessions at RAPS Convergence San Jose 2016 - Featured Image

Greenlight Guru Invited to Host Two Workshop Sessions at RAPS Convergence San Jose 2016

By Nick Tippmann on August 17, 2016
Be sure to come out and meet some of the Greenlight Guru team at the RAPS Convergence in San Jose Se...
How To Avoid Being Part of the 69% of 510(k) Submissions That Get Rejected the First Time - Featured Image

How To Avoid Being Part of the 69% of 510(k) Submissions That Get Rejected the First Time

By Jon Speer on August 15, 2016
Did you know that 69% of 510(k) submissions were rejected the first time between January and June of...
Insider Tips and Best Practices Regarding the 510(k) Submission Process with Allison Komiyama, a Former FDA Reviewer - Featured Image

Insider Tips and Best Practices Regarding the 510(k) Submission Process with Allison Komiyama, a Former FDA Reviewer

By Nick Tippmann on August 11, 2016
One important piece of documentation that medical device companies rely on to get them through the r...
Why Use ISO 14971 vs. FMEA (Template Included) - Featured Image

Why Use ISO 14971 vs. FMEA (Template Included)

By Jesseca Lyons on August 1, 2016
This may be stating the obvious, but engineers are generally very analytical. One of the areas where...
Insights Into the New FDA 3D Printing Guidance & How It Impacts Med Device New Product Development - Featured Image

Insights Into the New FDA 3D Printing Guidance & How It Impacts Med Device New Product Development

By Nick Tippmann on July 28, 2016
3D printing can impact new product development and manufacturing. It’s a technology that is hot in m...
Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): Understanding the Differences and What Documents to Include - Featured Image

Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): Understanding the Differences and What Documents to Include

By Jesseca Lyons on July 25, 2016
DHF. DMR. DHR.
3 Common Misconceptions About Medical Device Packaging - Featured Image

3 Common Misconceptions About Medical Device Packaging

By Jesseca Lyons on July 18, 2016
If you asked people what comes to mind when you say designing a medical device, you’re likely going ...
5 Places Paper Might Be Hiding in Your Medical Device Company - Featured Image

5 Places Paper Might Be Hiding in Your Medical Device Company

By Jesseca Lyons on July 11, 2016
A few weeks ago you left a big pile of paperwork (also known as your Document Change Order (DCO/ECO)...
3 Common Misconceptions About Medical Device Labeling - Featured Image

3 Common Misconceptions About Medical Device Labeling

By Jesseca Lyons on June 29, 2016
When you first start designing and developing a new medical device, you spend a bunch of time learni...
What It Means to Join the Greenlight Guru Family - Featured Image

What It Means to Join the Greenlight Guru Family

By Jesseca Lyons on June 27, 2016
When your medical device company makes the decision to go with Greenlight Guru, you might think that...
Recovery Force Accelerates Their Product Development Efforts Using Greenlight Guru [Case Study] - Featured Image

Recovery Force Accelerates Their Product Development Efforts Using Greenlight Guru [Case Study]

By Nick Tippmann on June 22, 2016
With its innovative technology in the highly competitive and expanding compression therapy market, i...
8 Reasons Why Your Design Controls And Risk Management Processes Fail - Featured Image

8 Reasons Why Your Design Controls And Risk Management Processes Fail

By Jon Speer on June 20, 2016
Design controls and risk management processes should be tools for MedTech professionals to ensure th...
What Medtech Startups Should Know About Quality Systems To Not Go Overboard - Featured Image

What Medtech Startups Should Know About Quality Systems To Not Go Overboard

By David Amor on June 16, 2016
MedTech startups thrive on lean-ness. Part of lean-ness is knowing how and when to scale regulatory ...
Preparing Your Class II Device for the UDI Compliance Deadline with Reed Tech’s Gary Saner - Featured Image

Preparing Your Class II Device for the UDI Compliance Deadline with Reed Tech’s Gary Saner

By Nick Tippmann on June 14, 2016
If you are part of an organization developing or producing Class II medical devices, you should know...
5 Medical Device Project Management Tips That Will Help You Complete Your Project On Time - Featured Image

5 Medical Device Project Management Tips That Will Help You Complete Your Project On Time

By Jesseca Lyons on June 13, 2016
If you’re an engineer at a small medical device company, chances are, at some point, you’re going to...
7 Steps to Respond to FDA 483 Inspection Observations (Response Template Included) - Featured Image

7 Steps to Respond to FDA 483 Inspection Observations (Response Template Included)

By Jon Speer on June 8, 2016
Attention: If you are a medical device company and you have class II or class III products registere...
Dirty Devices and Reprocessing: Are New Design Change Rules On the Horizon? - Featured Image

Dirty Devices and Reprocessing: Are New Design Change Rules On the Horizon?

By Nick Tippmann on June 1, 2016
As medical device developers, it is our responsibilities to make sure that our products are safe and...
4 Medical Device Quality System Musts for Startups - Featured Image

4 Medical Device Quality System Musts for Startups

By Jon Speer on May 31, 2016
Medical device startups have a pile of things to address yet often don’t have the pile of money to t...
4 Lessons I Learned Going Through an FDA / ISO Audit for the First Time as an Engineer - Featured Image

4 Lessons I Learned Going Through an FDA / ISO Audit for the First Time as an Engineer

By Jesseca Lyons on May 24, 2016
As an engineer, there’s not a lot that makes me nervous. Going through an FDA / ISO audit? That make...
Tips to Help You Prepare for an FDA Inspection - Featured Image

Tips to Help You Prepare for an FDA Inspection

By Nick Tippmann on May 23, 2016
On today’s episode, we’re introducing the newest addition to the Greenlight Guru team, Jesseca Lyons...
Best Practices for an Effective Medical Device Design Transfer Process - Featured Image

Best Practices for an Effective Medical Device Design Transfer Process

By Jesseca Lyons on May 23, 2016
With everything there is out there on the subject of Design Controls, you’d expect to find more on t...
Top 9 Reasons Device Makers Received FDA Form 483 and Warning Letters in 2015 - Featured Image

Top 9 Reasons Device Makers Received FDA Form 483 and Warning Letters in 2015

By Jon Speer on May 16, 2016
When was your last FDA inspection?
What Device Makers Need to Know About Design Verification and Validation with Mike Drues - Featured Image

What Device Makers Need to Know About Design Verification and Validation with Mike Drues

By Nick Tippmann on May 10, 2016
Here’s a question for our listeners: When it comes to making sure your medical devices are safe and ...
Understanding Risk in Medical Device New Product Development (NPD) - Featured Image

Understanding Risk in Medical Device New Product Development (NPD)

By Jeff Groh on May 9, 2016
New product development (NPD) consists of workflow, decision and information flow across multiple fu...
Why Integrating Business Elements into Your Medtech Development Process Is So Important with Therese Graff - Featured Image

Why Integrating Business Elements into Your Medtech Development Process Is So Important with Therese Graff

By Nick Tippmann on May 4, 2016
On today’s episode of the Global Medical Device podcast, we’re talking about the importance of incor...
How to Avoid Medical Device Product Development Wipeouts with Meghan Alonso - Featured Image

How to Avoid Medical Device Product Development Wipeouts with Meghan Alonso

By Nick Tippmann on April 27, 2016
Getting started in the medical product development process can be a huge undertaking. You might have...
Debunking 4 Commonly Held Design Control Myths - Featured Image

Debunking 4 Commonly Held Design Control Myths

By Jon Speer on April 25, 2016
The design control struggle is real.What is the struggle, you ask? Design controls are not being use...
3 Tips for Managing Your Medical Device Design History File - Featured Image

3 Tips for Managing Your Medical Device Design History File

By Jon Speer on April 21, 2016
Developing a cutting edge medical device can be really fun and exciting.
The Difference Between Intended Use and Indications of Use (And Why These Statements Are So Important) - Featured Image

The Difference Between Intended Use and Indications of Use (And Why These Statements Are So Important)

By Nick Tippmann on April 19, 2016
It’s time to break down the how and why of intended use and indications of use statements for your n...
Is Your Company Disconnected from the Medical Device Regulations It Must Abide By? - Featured Image

Is Your Company Disconnected from the Medical Device Regulations It Must Abide By?

By Jon Speer on April 14, 2016
As I type this post, I must admit that I’m a little perplexed. It seems medical device company after...
8 Questions That Define Your Medical Device User Needs - Featured Image

8 Questions That Define Your Medical Device User Needs

By Jon Speer on April 7, 2016
When people talk about U.S. Food and Drug Administration (FDA) design controls, they often place a l...
Why the Conventional Wisdom Regarding ‘R’ and ‘D’ in Medtech Product Development Is Wrong with David Amor - Featured Image

Why the Conventional Wisdom Regarding ‘R’ and ‘D’ in Medtech Product Development Is Wrong with David Amor

By Nick Tippmann on March 30, 2016
Today on the Global Medical Device Podcast we have a very interesting and highly debated topic for y...
Acronyms You Need To Know When Evaluating Medical Device Software Solutions - Featured Image

Acronyms You Need To Know When Evaluating Medical Device Software Solutions

By Jon Speer on March 29, 2016
Ah, yes! You aspire to run your device company in a paperless environment. Allowing you to capture a...
6 Medical Device Product Development Steps To Fast-Track Your Path To Market - Featured Image

6 Medical Device Product Development Steps To Fast-Track Your Path To Market

By Jon Speer on March 28, 2016
This article originally appeared as a guest expert post on Med Device Online. Congratulations! You h...
Why Medical Device Startups Need to Master Juggling and Balancing With Focus - Featured Image

Why Medical Device Startups Need to Master Juggling and Balancing With Focus

By Jon Speer on March 17, 2016
Medical device startups are faced with numerous challenges and obstacles to get their products to ma...
How Design Controls Apply to the 510(k) Process - Featured Image

How Design Controls Apply to the 510(k) Process

By Jon Speer on March 14, 2016
If you are developing a medical device for the U.S. market, you first need to determine how your dev...
Why FMEA is Not ISO 14971 Risk Management - Featured Image

Why FMEA is Not ISO 14971 Risk Management

By Jon Speer on March 10, 2016
If you are still using FMEA as your methodology to capture medical device risk management activities...
Top 3 Document Management Tips for Medical Device Companies - Featured Image

Top 3 Document Management Tips for Medical Device Companies

By Jon Speer on February 29, 2016
In the medical device industry, one absolute—which shows no signs of abating—is the need to maintain...
Medical Device Product Development Project Management Best Practices with Peter Sebelius - Featured Image

Medical Device Product Development Project Management Best Practices with Peter Sebelius

By Nick Tippmann on February 23, 2016
Another brilliant mind joins us today on the Global Medical Device Podcast. Peter Sebelius is the fo...
How To Navigate the Difficult Road of Medical Device Product Development While Avoiding the Common Pitfalls - Featured Image

How To Navigate the Difficult Road of Medical Device Product Development While Avoiding the Common Pitfalls

By Jon Speer on February 22, 2016
Click here to enlarge image. The story I’m about to tell you is about Eddy Engineer and his trials a...
4 Reasons Why Your Risk Management Approach is Wrong - Featured Image

4 Reasons Why Your Risk Management Approach is Wrong

By Jon Speer on February 16, 2016
This article originally appeared as a guest post on MedTech Intelligence. A few months ago, I predic...
Why Using the Proper Standards for Your Regulatory Submission is So Important with Leo Eisner - Featured Image

Why Using the Proper Standards for Your Regulatory Submission is So Important with Leo Eisner

By Nick Tippmann on February 10, 2016
Standards are absolutely critical when you are developing a medical device. You need to understand w...
Best Document Management Practices for Medical Device Startups: Don’t Cheap Out - Featured Image

Best Document Management Practices for Medical Device Startups: Don’t Cheap Out

By Alex Morris on February 4, 2016
Vendor-supplied document management systems have loads of advantages that even the youngest startup ...
The Risk Management + Design Controls Connection: What Device Makers Need to Know - Featured Image

The Risk Management + Design Controls Connection: What Device Makers Need to Know

By Jon Speer on February 1, 2016
Part 1: Intended Use & User Needs Medical devices are intended to save and improve quality of life. 
An Insider’s Look at the Changes Coming in ISO 13485:2016 with Mark Swanson, a Member of the Standard's Working Group - Featured Image

An Insider’s Look at the Changes Coming in ISO 13485:2016 with Mark Swanson, a Member of the Standard's Working Group

By Jon Speer on January 18, 2016
Did you know ISO 13485 has been revised and approved in 2016? And is going to be published later thi...
The Definitive Guide to Responding to FDA 483 Observations and Warning Letters - Featured Image

The Definitive Guide to Responding to FDA 483 Observations and Warning Letters

By Jon Speer on January 13, 2016
Should you ever have an FDA inspection, you’re going to want to know what to do after.
ISO 13485 and FDA QSR: A Step-by-Step Guide to Complying with Medical Device QMS Requirements - Featured Image

ISO 13485 and FDA QSR: A Step-by-Step Guide to Complying with Medical Device QMS Requirements

By Jon Speer on January 4, 2016
Medical device companies, listen up. There is zero excuse for not complying with medical device qual...
The Greenlight Guru Advantage - More Than QMS Software [Customer Video Testimonial] - Featured Image

The Greenlight Guru Advantage - More Than QMS Software [Customer Video Testimonial]

By Jon Speer on December 28, 2015
What do you know about Greenlight Guru? Your first thought may be that Greenlight Guru is a software...
Why Medical Device Startups Need to Implement a ‘Right-Sized’ QMS with David Amor - Featured Image

Why Medical Device Startups Need to Implement a ‘Right-Sized’ QMS with David Amor

By Nick Tippmann on December 15, 2015
If you are in the business of medical devices, then you must eat, breathe, and live quality manageme...
20 Most Popular Medical Device Posts of 2015 from greenlight guru - Featured Image

20 Most Popular Medical Device Posts of 2015 from greenlight guru

By Nick Tippmann on December 14, 2015
2015 was a huge year for Greenlight Guru! A lot happened. From publically launching our product in F...
Why Design Inputs Are So Important to the Success or Failure of Your Project with Matt Romey - Featured Image

Why Design Inputs Are So Important to the Success or Failure of Your Project with Matt Romey

By Nick Tippmann on December 9, 2015
In episode #10 of the Global Medical Device podcast we welcome Matt Romey from the Azzur Group. Matt...
Why Getting FDA 510(k) Clearance Alone is Not Enough (And 6 Things You Can Do About It) - Featured Image

Why Getting FDA 510(k) Clearance Alone is Not Enough (And 6 Things You Can Do About It)

By Jon Speer on December 9, 2015
Getting FDA 510(k) market clearance is a significant, meaningful milestone and achievement for any m...
LITG Case Study: Easily Documenting Design Controls to Accelerate Product Development - Featured Image

LITG Case Study: Easily Documenting Design Controls to Accelerate Product Development

By Jon Speer on December 3, 2015
    "Medical device companies must document Design Controls, yet most struggle with this. Greenlight...
Sandstone Diagnostics Case Study: Moving from a Paper-based QMS to Greenlight Guru - Featured Image

Sandstone Diagnostics Case Study: Moving from a Paper-based QMS to Greenlight Guru

By Jon Speer on December 2, 2015
  “The proof is in the pudding. We passed our California audit with flying colors. She was in and ou...
5 Reasons Why You Need To Implement a QMS or Bust - Featured Image

5 Reasons Why You Need To Implement a QMS or Bust

By Jon Speer on December 1, 2015
Look, I get it. Worrying about implementing a quality management system isn't on your list of the to...
How To Identify, Quantify and Manage Enterprise Risks for Medical Device Companies with Mike Cremeans - Featured Image

How To Identify, Quantify and Manage Enterprise Risks for Medical Device Companies with Mike Cremeans

By Nick Tippmann on November 25, 2015
In episode #9 of the Global Medical Device Podcast we’re joined by Mike Cremeans. Mike is the Vice P...
How To Avoid Major Common Mistakes During the FDA 510(k) Process with Michael Drues - Featured Image

How To Avoid Major Common Mistakes During the FDA 510(k) Process with Michael Drues

By Nick Tippmann on November 20, 2015
In episode #8 of the Global Medical Device Podcast we welcome back Michael Drues, president of Vascu...
15 Items Medical Device Startups Need to Address - Featured Image

15 Items Medical Device Startups Need to Address

By Jon Speer on November 16, 2015
As a medical device startup, there are many things you are juggling and balancing all day, every day...
Tips, Tricks and Pointers for MedTech Startup Entrepreneurs With Mitch Levinson - Featured Image

Tips, Tricks and Pointers for MedTech Startup Entrepreneurs With Mitch Levinson

By Nick Tippmann on November 4, 2015
We’re discussing how startup entrepreneurs like you can remove the common regulatory obstacles your ...
Paper Systems Are the Riskiest Way to Manage Medical Device Projects - Featured Image

Paper Systems Are the Riskiest Way to Manage Medical Device Projects

By Jon Speer on October 28, 2015
Did you know that over 50% of medical device companies still use manual, paper-based approaches for ...
greenlight guru Wins 2015 Indiana Innovation Award - Featured Image

greenlight guru Wins 2015 Indiana Innovation Award

By Nick Tippmann on October 23, 2015
   
The Definitive Guide to ISO 14971 Risk Management for Medical Devices - Featured Image

The Definitive Guide to ISO 14971 Risk Management for Medical Devices

By Jon Speer on October 5, 2015
The Many Connotations Of Risk In Medtech Development — And The Consequences Of Getting Them Wrong - Featured Image

The Many Connotations Of Risk In Medtech Development — And The Consequences Of Getting Them Wrong

By Michael Drues, Ph.D. on September 28, 2015
Risk assessment and risk management in the medical device industry typically start with a brainstorm...
How Proper Design Controls & a Quality System Could Save You $20M With Ronny Bracken - Featured Image

How Proper Design Controls & a Quality System Could Save You $20M With Ronny Bracken

By Nick Tippmann on September 22, 2015
What are the most common mistakes a startup medical device company usually make? Hear Ronny Bracken ...
Sara Naab On Going From Idea to Funding to One of the Bay Area's Most Innovative Life Sciences Companies - Featured Image

Sara Naab On Going From Idea to Funding to One of the Bay Area's Most Innovative Life Sciences Companies

By Nick Tippmann on September 17, 2015
In today’s episode of the Global Medical Device Podcast Jon Speer welcomes Sara Naab to the show.
Does Your Medical Device Startup Suffer from CEO Disconnect Syndrome? - Featured Image

Does Your Medical Device Startup Suffer from CEO Disconnect Syndrome?

By Jon Speer on September 10, 2015
I’d like to take a few minutes to share with you a story. One where a CEO of a medical device startu...
Risk Management from a Regulatory & Product Development Perspective [Podcast] - Featured Image

Risk Management from a Regulatory & Product Development Perspective [Podcast]

By Nick Tippmann on September 2, 2015
  Risk management for medical devices from a regulatory and product development perspective is the t...
How To Flush $400,000 Down the Drain Fighting the FDA - Featured Image

How To Flush $400,000 Down the Drain Fighting the FDA

By Jon Speer on August 31, 2015
How much does it cost to address FDA 483 observation and warning letter issues? Unless you have been...
How To Improve Your Design Reviews (Bonus Episode) - Featured Image

How To Improve Your Design Reviews (Bonus Episode)

By Nick Tippmann on August 14, 2015
Medical device design reviews - are more or less better? What about independent reviews? Are they ne...
3 Tips for Incorporating Risk Management Throughout Medical Device Product Development - Featured Image

3 Tips for Incorporating Risk Management Throughout Medical Device Product Development

By Jon Speer on August 10, 2015
Medical device product development and risk management are often treated as entirely separate proces...
Understanding ISO 14971 Medical Device Risk Management - Featured Image

Understanding ISO 14971 Medical Device Risk Management

By Jon Speer on August 6, 2015
Medical device companies MUST have established risk management processes that comply with ISO 14971.
Design Reviews – Are More or Less Better? - Featured Image

Design Reviews – Are More or Less Better?

By Jon Speer on August 3, 2015
Design Reviews are critical to the success of medical device product development. 
A Brief Introduction to Medical Device Risk Management (Plus 5 Tips) - Featured Image

A Brief Introduction to Medical Device Risk Management (Plus 5 Tips)

By Jon Speer on July 15, 2015
Risk management will have the most significant impact on the medical device industry within the next...
How To Improve Your Medical Device Design Reviews - Featured Image

How To Improve Your Medical Device Design Reviews

By Nick Tippmann on July 7, 2015
Medical device Design Reviews are critical steps within your design and development process. They pr...
How To Avoid a Medtech Documents & Records Scavenger Hunt - Featured Image

How To Avoid a Medtech Documents & Records Scavenger Hunt

By Jon Speer on June 19, 2015
I love a scavenger hunt as much as the next person. However, when it comes to medical device documen...
Join Us in Memphis for #ZeroToGreenlight - Why Worrying About FDA Regulations Matters - Featured Image

Join Us in Memphis for #ZeroToGreenlight - Why Worrying About FDA Regulations Matters

By Nick Tippmann on June 18, 2015
Clear your calendar - It's going down! As part of the ZeroTo510 Thought Leaders Series, Zero To Gree...
Should design controls have prevented the recent reprocessing tragedy: Do we need new regulation? - Featured Image

Should design controls have prevented the recent reprocessing tragedy: Do we need new regulation?

By Nick Tippmann on June 12, 2015
Superbugs.  Reprocessing. The White House. And Design Controls. Probably not a combo of topics you s...
5 Tips to Help Your FDA 510(k) Submission (checklist included) - Featured Image

5 Tips to Help Your FDA 510(k) Submission (checklist included)

By Jon Speer on May 21, 2015
If you are developing a medical device in the United States, there is a good chance your path to mar...
The Beginner's Guide to Design Verification and Design Validation for Medical Devices - Featured Image

The Beginner's Guide to Design Verification and Design Validation for Medical Devices

By Jon Speer on May 6, 2015
When your medical device product development project gets to Design Verification and Design Validati...
Best Practices for Implementing Design Controls for the Medical Device Industry - Featured Image

Best Practices for Implementing Design Controls for the Medical Device Industry

By Nick Tippmann on April 16, 2015
If you're like many in the medical device industry, you've probably had some questions at one time o...
2 Things You Need To Do ASAP When Starting A Medical Device Project - Featured Image

2 Things You Need To Do ASAP When Starting A Medical Device Project

By Jon Speer on February 17, 2015
It's hard to believe I've been in the medical device industry since 1998. I have learned so much and...
How To Reduce & Prevent Medical Device Complaints - Featured Image

How To Reduce & Prevent Medical Device Complaints

By Jon Speer on November 13, 2014
Congratulations! You have successfully launched a new medical device after months and months of prod...
Medical Device Product Development Case Study - Featured Image

Medical Device Product Development Case Study

By Jon Speer on October 3, 2014
Medical Device product development is a very challenging endeavor. Even the simplest product develop...
Changing Medical Device Design Control - Featured Image

Changing Medical Device Design Control

By Jon Speer on September 18, 2014
As a development engineer in the medical device industry, it has been my experience that using and f...
You do know Design Controls are required for medical devices, right? - Featured Image

You do know Design Controls are required for medical devices, right?

By Jon Speer on September 9, 2014
So you're developing a medical device? Congratulations!
An FDA Inspection Will Happen - Featured Image

An FDA Inspection Will Happen

By Jon Speer on August 30, 2014
If you are a medical device company in the U.S., did you know FDA is required to inspect all class I...
Design Controls Need to Start With User Needs - Featured Image

Design Controls Need to Start With User Needs

By Jon Speer on August 21, 2014
If you are engaged in medical device product development, then you likely know about the importance ...
Design Controls are the #1 Most Cited Issue with FDA - Featured Image

Design Controls are the #1 Most Cited Issue with FDA

By Jon Speer on August 9, 2014
Did you know that Design Controls were the #1 issue cited by FDA during 2013?

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