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Identifying the Positive and Negative Effects of COVID-19 on the Medical Device Industry - Featured Image

Identifying the Positive and Negative Effects of COVID-19 on the Medical Device Industry

By Nick Tippmann on June 3, 2020
Most of us have read about, observed, participated in, and spoke with healthcare providers and medic...
Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): What's the Difference? - Featured Image

Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): What's the Difference?

By Jesseca Lyons on May 29, 2020
The medical device industry has a lot of acronyms. 
How to Construct an Effective Regulatory Strategy - Featured Image

How to Construct an Effective Regulatory Strategy

By Nick Tippmann on May 27, 2020
What is a regulatory strategy? What are the components involved?
22 MedTech Experts Share Best Tips for Product Developers, QA/RA Professionals & Leadership Roles - Featured Image

22 MedTech Experts Share Best Tips for Product Developers, QA/RA Professionals & Leadership Roles

By Jon Speer on May 24, 2020
The Greenlight Guru True Quality Virtual Summit is the must-attend experience for medical device qua...
What you Need to Know about Clinical Evaluation & Validation for Software as a Medical Device (SaMD) - Featured Image

What you Need to Know about Clinical Evaluation & Validation for Software as a Medical Device (SaMD)

By Nick Tippmann on May 20, 2020
Does your software as a medical device (SaMD) function properly? Does it meet the needs of the end u...
EUA 101: What is Emergency Use Authorization and How can my Device get Authorized? - Featured Image

EUA 101: What is Emergency Use Authorization and How can my Device get Authorized?

By Jon Speer on May 17, 2020
On Saturday, March 28, health care workers in Los Angeles County discovered that the federal governm...
How to Use Artificial Intelligence & Machine Learning to Produce Better, Smarter, Safer Devices - Featured Image

How to Use Artificial Intelligence & Machine Learning to Produce Better, Smarter, Safer Devices

By Nick Tippmann on May 13, 2020
What is artificial intelligence (AI) and machine learning (ML) and how do the two differ in the medi...
510(k) Tips and Answers to Frequently Asked Questions for Medical Device Companies - Featured Image

510(k) Tips and Answers to Frequently Asked Questions for Medical Device Companies

By Nick Tippmann on May 6, 2020
What does the 510(k) process involve? How should medical device companies know if this is the right ...
EU MDR Delay: How to Plan Beyond the Coronavirus Pandemic - Featured Image

EU MDR Delay: How to Plan Beyond the Coronavirus Pandemic

By Jon Speer on May 3, 2020
The EU Medical Device Regulation (MDR) has been a source of stress for medical device companies arou...
How COVID-19 is Impacting the Medical Device Industry: Data, Benchmarks & Trends - Featured Image

How COVID-19 is Impacting the Medical Device Industry: Data, Benchmarks & Trends

By Jon Speer on May 3, 2020
Medical device companies are among the most important players in the world’s response to COVID-19.
Addressing the PPE Shortage with a No Cost Solution for Healthcare Providers - Featured Image

Addressing the PPE Shortage with a No Cost Solution for Healthcare Providers

By Nick Tippmann on April 29, 2020
Are you a medical provider or caregiver unable to find facemasks as PPE for COVID-19? Get one for fr...
Greenlight Guru and EMERGO by UL Announce Strategic Alliance to Simplify and Automate Global Market Access for Medical Device Companies - Featured Image

Greenlight Guru and EMERGO by UL Announce Strategic Alliance to Simplify and Automate Global Market Access for Medical Device Companies

By Nick Tippmann on April 27, 2020
Bundled offerings equip medical device manufacturers to better navigate regulatory pathways, bring d...
[LIVE] How EU MDR Changes are Impacting the Medical Device Ecosystem - Featured Image

[LIVE] How EU MDR Changes are Impacting the Medical Device Ecosystem

By Nick Tippmann on April 22, 2020
What impact will the EU MDR changes have on the medical device ecosystem?
Documentation Priority for Early Stage Medtechs — Part 1: User Specification - Featured Image

Documentation Priority for Early Stage Medtechs — Part 1: User Specification

By Tommy Cooper on April 19, 2020
A common dilemma for early stage medical device companies is their lack of expertise in medical devi...
How to Approach Verification and Validation for Cloud Software - Featured Image

How to Approach Verification and Validation for Cloud Software

By Nick Tippmann on April 15, 2020
Why is verification and validation (V&V) confusing and challenging for many medical device professio...
How Software Architecture Enables Faster Release of New Clinical Tests to the Market - Featured Image

How Software Architecture Enables Faster Release of New Clinical Tests to the Market

By The RND Group on April 12, 2020
The ultimate goal of developing a medical device is to receive FDA approval and to be able to releas...
What are the Changes to ISO 14971:2019 & TR 24971? - Featured Image

What are the Changes to ISO 14971:2019 & TR 24971?

By Jon Speer on April 12, 2020
Proper risk management is a key process throughout the entire life cycle of a medical device. This i...
Fighting COVID-19: How one MedTech Company is Using UV-C Technology to Eliminate Virus & Save Lives - Featured Image

Fighting COVID-19: How one MedTech Company is Using UV-C Technology to Eliminate Virus & Save Lives

By Nick Tippmann on April 10, 2020
During the COVID-19 crisis, medical device companies are improving and saving the lives of healthcar...
Emergency Use Authorization (EUA) 101: What Medical Device Companies Need to Know - Featured Image

Emergency Use Authorization (EUA) 101: What Medical Device Companies Need to Know

By Nick Tippmann on April 8, 2020
What qualifies and what does not for Emergency Use Authorization (EUA)? What is the impact of this r...
COVID-19 Impact on Medical Device Industry: How to Navigate the Chaos and Support Public Health - Featured Image

COVID-19 Impact on Medical Device Industry: How to Navigate the Chaos and Support Public Health

By Jon Speer on April 5, 2020
COVID-19 has thrown the medical community into a frenzy. Hospitals are struggling as the disease spr...
10 Ways A Modern, Cloud-Based MDQMS Helps Remote Teams Stay Ahead - Featured Image

10 Ways A Modern, Cloud-Based MDQMS Helps Remote Teams Stay Ahead

By Nick Tippmann on April 4, 2020
During unprecedented times, medical device companies are finding themselves facing unusual challenge...
How to Integrate Usability into your Medical Device - Featured Image

How to Integrate Usability into your Medical Device

By Nick Tippmann on April 1, 2020
Medical device usability is a critical, yet confusing component of medical device design, developmen...
4 Emerging Trends in 2020 Backed by Medical Device Industry Experts - Featured Image

4 Emerging Trends in 2020 Backed by Medical Device Industry Experts

By Jon Speer on March 29, 2020
Throughout 2020, the medical device industry will see significant changes take flight. Among the big...
[LIVE] Design Controls, Development, and Risk for Software as a Medical Device (SaMD) - Featured Image

[LIVE] Design Controls, Development, and Risk for Software as a Medical Device (SaMD)

By Nick Tippmann on March 26, 2020
In this modern digital world, did you know that most medical devices are not connected to the Intern...
Medical Device Companies - Top 100 in 2020 (Free Chart) - Featured Image

Medical Device Companies - Top 100 in 2020 (Free Chart)

By Nick Tippmann on March 24, 2020
Have you ever wondered about the biggest medical device companies in the world? Maybe you're looking...
Only 6% of Device Makers Are Ready for EU MDR — Are You? Here are 3 Ways to Transition Now - Featured Image

Only 6% of Device Makers Are Ready for EU MDR — Are You? Here are 3 Ways to Transition Now

By Jon Speer on March 22, 2020
With the deadline for compliance with the EU MDR just around the corner, big changes are being made ...
How to Leverage IEC 62304 to improve SaMD Development Processes - Featured Image

How to Leverage IEC 62304 to improve SaMD Development Processes

By Nick Tippmann on March 18, 2020
How can the IEC 62304 standard serve as a framework for your Software as a Medical Device (SaMD) dev...
What is the eSTAR Pilot Program and How Will it Improve FDA's 510(k) Review Process? - Featured Image

What is the eSTAR Pilot Program and How Will it Improve FDA's 510(k) Review Process?

By Nick Tippmann on March 12, 2020
The FDA announced another new pilot program to improve the consistency and efficiency of its 510(k) ...
Greenlight Guru Updates Risk Management Capabilities to Align with ISO 14971:2019, Further Enhances Change Management Capabilities - Featured Image

Greenlight Guru Updates Risk Management Capabilities to Align with ISO 14971:2019, Further Enhances Change Management Capabilities

By Nick Tippmann on March 9, 2020
Medical device quality management system (MDQMS) aligns with latest version of globally recognized r...
Best QMS Software: Ultimate Guide to Comparing Quality Management System Solutions - Featured Image

Best QMS Software: Ultimate Guide to Comparing Quality Management System Solutions

By Jon Speer on March 1, 2020
How a company chooses to establish and maintain their quality system has everything to do with their...
How to Choose the Right FDA Regulatory Pathway for your Device - Featured Image

How to Choose the Right FDA Regulatory Pathway for your Device

By Nick Tippmann on February 26, 2020
Most medical device professionals and companies are familiar with Premarket Approval (PMA) and 510(k...
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 February 25, 2020
FDA Form 483 Observations and Warning Letters - What’s the Difference? - Featured Image

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

By Jon Speer on February 21, 2020
If you’re a medical device company manufacturing Class II or Class III devices, you can expect to ha...
How to Establish a Solid Foundation for Fundraising and Product Success by Focusing on Regulatory - Featured Image

How to Establish a Solid Foundation for Fundraising and Product Success by Focusing on Regulatory

By Nick Tippmann on February 19, 2020
Regulatory is a big deal for medical device companies. Whether it’s a startup or established busines...
7 FDA Pathways to Bring Your Medical Device to Market - Featured Image

7 FDA Pathways to Bring Your Medical Device to Market

By Tom Rish on February 16, 2020
Anyone reading this who is planning to launch a medical device in the U.S. has likely heard of the 5...
[VIDEO] How to Calculate the Cost Of Quality: Building the Business Case for your Medical Device QMS - Featured Image

[VIDEO] How to Calculate the Cost Of Quality: Building the Business Case for your Medical Device QMS

By Jon Speer on February 14, 2020
How can I justify the costs of implementing medical device specific quality management software at m...
[VIDEO] 7 Ways to Track QMS Effectiveness using Medical Device Post-market Quality Processes (Track Phase) - Featured Image

[VIDEO] 7 Ways to Track QMS Effectiveness using Medical Device Post-market Quality Processes (Track Phase)

By Jon Speer on February 14, 2020
How can I track the effectiveness of my QMS after my medical device goes to market? We'll cover the ...
[VIDEO] How to Prepare your QMS for a Successful Medical Device Product Launch (Release Phase) - Featured Image

[VIDEO] How to Prepare your QMS for a Successful Medical Device Product Launch (Release Phase)

By Jon Speer on February 14, 2020
Is my QMS ready for the product launch of my medical device? Which quality processes should I implem...
[VIDEO] 4 Medical Device Manufacturing Best Practices for a Successful Design Transfer (Approve Phase) - Featured Image

[VIDEO] 4 Medical Device Manufacturing Best Practices for a Successful Design Transfer (Approve Phase)

By Jon Speer on February 14, 2020
How can I prepare my QMS to approve my medical device for manufacturing from a design transfer? Lear...
[VIDEO] Integrating Design Controls & Risk Management To Streamline Product Development (Make Phase) - Featured Image

[VIDEO] Integrating Design Controls & Risk Management To Streamline Product Development (Make Phase)

By Jon Speer on February 14, 2020
Which QMS processes should be established during product development? We'll explain how design contr...
[VIDEO] 3 Easy Steps to Establishing a Quality & Regulatory Strategy for your Medical Device (Scope Phase) - Featured Image

[VIDEO] 3 Easy Steps to Establishing a Quality & Regulatory Strategy for your Medical Device (Scope Phase)

By Jon Speer on February 14, 2020
How do I know which regulations apply to my medical device? What should I include in my quality plan...
[VIDEO] How to build a medical device QMS using the best people, processes & technology (S.M.A.R.T Methodology) - Featured Image

[VIDEO] How to build a medical device QMS using the best people, processes & technology (S.M.A.R.T Methodology)

By Jon Speer on February 14, 2020
Which quality processes should I establish first when implementing a medical device quality manageme...
4 Parts to Interviewing Candidates for Medical Device Roles - Featured Image

4 Parts to Interviewing Candidates for Medical Device Roles

By Nick Tippmann on February 12, 2020
Are you looking to hire medical device professionals? Or, are you a professional seeking new job opp...
Understanding Post-Market Surveillance Requirements for Medical Devices (US & EU Markets) - Featured Image

Understanding Post-Market Surveillance Requirements for Medical Devices (US & EU Markets)

By Taylor Brown on February 9, 2020
As leaders of medical device companies, our goal is always to create devices that are safe and effec...
5 Tips for Hiring Medical Device Advisors - Featured Image

5 Tips for Hiring Medical Device Advisors

By Nick Tippmann on February 5, 2020
Everybody seeks advice and opinions from others from time to time, even those in the medical device ...
2 Key Areas Missing from FDA CDRH's Regulatory Science Priorities for 2020 - Featured Image

2 Key Areas Missing from FDA CDRH's Regulatory Science Priorities for 2020

By Nick Tippmann on January 29, 2020
What top priorities can medical device professionals and patients expect in 2020 from the Center for...
4 Major Reasons to Use Document Version Control Software for your Medical Device - Featured Image

4 Major Reasons to Use Document Version Control Software for your Medical Device

By Taylor Brown on January 26, 2020
With the incredible volume of documentation required by the FDA and ISO, using a document control sy...
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...
FDA 21 CFR Part 820: 8 Most Common Mistakes to Avoid - Featured Image

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

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...
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.

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