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Submitting a 510(k) using FDA's Safety and Performance Based Pathway - Featured Image

Submitting a 510(k) using FDA's Safety and Performance Based Pathway

By Nick Tippmann on September 2, 2020
What is FDA’s Safety and Performance Based Pathway and how does it relate to the Traditional, Specia...
519 Medical Device Manufacturers Reveal Biggest Barriers to Process Improvement - Featured Image

519 Medical Device Manufacturers Reveal Biggest Barriers to Process Improvement

By Jon Speer on August 30, 2020
In the medical device industry, there’s a lot outside of our control. The market shifts. New, innova...
How Jon Speer Met His Most Frequent Guest: Mike Drues - Featured Image

How Jon Speer Met His Most Frequent Guest: Mike Drues

By Nick Tippmann on August 26, 2020
Reminiscing about past and present lessons learned from listening to conversations with this show’s ...
Document Control for Medical Device Companies: The Ultimate Guide - Featured Image

Document Control for Medical Device Companies: The Ultimate Guide

By Jon Speer on August 23, 2020
According to the original data findings of our 2020 State of Medical Device Product Development and ...
Meet a Guru: Wade Schroeder - Featured Image

Meet a Guru: Wade Schroeder

By Nick Tippmann on August 19, 2020
What sets Greenlight Guru apart from other quality management solutions? It’s Guru edge⁠—a team of m...
Unannounced Audits: A Survival Guide for Quality Managers - Featured Image

Unannounced Audits: A Survival Guide for Quality Managers

By Jon Speer on August 16, 2020
We’re in an industry that requires preparation. Unlike less regulated industries, there’s an expecta...
What are the Audit Etiquette Rules I Should be Following? - Featured Image

What are the Audit Etiquette Rules I Should be Following?

By Nick Tippmann on August 12, 2020
Who looks forward to audits? Not most people except for maybe the actual auditor. Hold yourself acco...
5 Tips for Medical Device Registration across Global Markets - Featured Image

5 Tips for Medical Device Registration across Global Markets

By Jon Speer on August 9, 2020
You have compiled all of the necessary documentation for your regulatory submission, submitted it to...
Meet a Guru: Tom Rish - Featured Image

Meet a Guru: Tom Rish

By Nick Tippmann on August 5, 2020
What makes Greenlight Guru so unique, beyond its medical device QMS (MDQMS) software? Its Guru edge.
How Do I Determine if my Product is a Medical Device? - Featured Image

How Do I Determine if my Product is a Medical Device?

By Jon Speer on August 2, 2020
Let’s say you’re in the medical industry but not yet in the medical device industry. You’re working ...
Addressing Clinical Trial Challenges & Concerns during COVID-19 - Featured Image

Addressing Clinical Trial Challenges & Concerns during COVID-19

By Nick Tippmann on July 29, 2020
The current COVID-19 pandemic and its impact on clinical trials has created a sense of chaos amongst...
What is FDA's Approach to Regulating AI/ML in Software as a Medical Device? - Featured Image

What is FDA's Approach to Regulating AI/ML in Software as a Medical Device?

By The RND Group on July 26, 2020
The FDA has released a discussion guideline and request for feedback regarding changes in the certif...

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