Medical Device Quality, Regulatory and Product Development Blog | Greenlight Guru

Free Template: Nonconformance Process for your Medical Device

By Jon Speer on October 20, 2020

Eventually, every quality professional is going to have to deal with nonconformance. In the medical ...

A Free CAPA Template for the Medical Device Industry

By Jon Speer on October 18, 2020

If you’re a medical device professional, you’ve likely heard the acronym “CAPA” before. For those wh...

How to Write a Nonconformance Report

By Barret Mueller on October 4, 2020

Nonconformance is a word no quality manager wants to hear.

Quality Assurance vs. Quality Control in the Medical Device Industry

By Jon Speer on September 6, 2020

Imagine that your medical device malfunctioned during patient use. Do you know whether quality assur...

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

By Nick Tippmann on August 26, 2020

Reminiscing about past and present lessons learned from listening to conversations with this show’s ...

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...

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

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?

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 ...

Top 100 Medical Device Acronyms & Terminology You Need to Know

By Jon Speer on July 19, 2020

In the medical device industry, knowledge is power. Your knowledge of medical device terminology emp...

Meet a Guru: Jesseca Lyons

By Nick Tippmann on July 15, 2020

What makes Greenlight Guru unique? It’s Guru edge, composed of a team of medical device experts with...

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