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Greenlight Guru Medical Device Blog

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Ultimate Guide to 21 CFR Part 820 — FDA's Quality System Regulation (QSR) for Medical Devices - Featured Image

Ultimate Guide to 21 CFR Part 820 — FDA's Quality System Regulation (QSR) for Medical Devices

Positive and Negative Impacts of EUA on the Medical Device Industry - Featured Image

Positive and Negative Impacts of EUA on the Medical Device Industry

As the COVID-19 global pandemic continues, emergency use authorization (EUA) has become a highly uti...
Meet a Guru: Erica Loring - Featured Image

Meet a Guru: Erica Loring

What makes Greenlight Guru unique? It’s Guru edge⁠—a team of medical device professionals with decad...
The Ultimate Internal Audit Checklist Every Medical Device Company Needs - Featured Image

The Ultimate Internal Audit Checklist Every Medical Device Company Needs

It was nothing more than a checklist that saved $175 million and 1,500 lives.
How Jon Speer Met His Most Frequent Guest: Mike Drues - Featured Image

How Jon Speer Met His Most Frequent Guest: Mike Drues

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

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

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

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?

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

You have compiled all of the necessary documentation for your regulatory submission, submitted it to...
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?

The FDA has released a discussion guideline and request for feedback regarding changes in the certif...
How to Build a QMS for a Medical Device - Featured Image

How to Build a QMS for a Medical Device

Where do you begin when building a quality management system (QMS) for a medical device? It’s a task...

The Greenlight Guru Medical Device Blog

Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.

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