Medical Device Quality, Regulatory and Product Development Blog

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]

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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 Greenlight Guru is laying the foundation for success at Amnion Life

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

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

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

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

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

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?

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

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...

FDA QSIT: Preparing Your Medical Device Company for an Inspection

By Jon Speer on February 17, 2019

Preparing for an FDA QSIT inspection can be a daunting task for medical device manufacturers. Many c...

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

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

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...

Top 35+ Medical Device Conferences To Attend in 2019

By Nick Tippmann on January 29, 2019

Simply attending the right conferences can be a game-changer for those in the medical device industr...

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

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

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

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?

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

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

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

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

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

By Jon Speer on January 1, 2019

Top 10 Most Popular Greenlight Guru Posts of 2018 - 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

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)

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?

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)

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

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

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

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

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)!

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

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

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

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

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)

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

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

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)

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

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)

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

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

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

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)

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

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

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

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)?

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

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)

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

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

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

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

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

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

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

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?

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)?

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

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

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

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

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

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)

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

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

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

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

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?

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

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

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

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

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!

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

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

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

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

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

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)

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)

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

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

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

By Jon Speer on May 7, 2018

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

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

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

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)

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)

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

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

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

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

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?

By Larry Mager on March 12, 2018

What's the difference between the two? Plenty!

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

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]

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

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)

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+)

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

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)

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

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

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

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

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

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

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

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

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)?

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

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

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

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

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)

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

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

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

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

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?

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

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?

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

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

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)

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

By Jon Speer on August 28, 2017

FDA has arrived at your premises…

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

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)

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

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

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

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

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

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

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?

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

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

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

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)

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

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

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...

8 Tips to Comply With FDA 21 CFR Part 11

By Jon Speer on May 22, 2017

When it comes to compliance among medical device companies, there is a lot of misleading information...

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!

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

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

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

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?

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?

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

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

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

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?

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

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?

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

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

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

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

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

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

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...

Best Practices for Expediting Your Medical Device Product Development

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?

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

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?

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

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)

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

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)

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

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

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

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

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

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

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

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)

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

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)

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

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

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

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?

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

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

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

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

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

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

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)

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

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

By Jesseca Lyons on July 25, 2016

DHF. DMR. DHR.

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