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Medical Device Biocompatibility 101 - Featured Image

Medical Device Biocompatibility 101

Medical device biocompatibility can be confusing, challenging, even frustrating for device professio...
Why Biocompatibility Should be Addressed by Every Medical Device Company - Featured Image

Why Biocompatibility Should be Addressed by Every Medical Device Company

Should your medical device company address biocompatibility? The short answer is, yes. Every single ...
Everything You Need to Know about Human Factors Engineering for Your Medical Device - Featured Image

Everything You Need to Know about Human Factors Engineering for Your Medical Device

Human factors are a key part of medical device development and the sooner they’re addressed in the d...
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.
Free Complaint Template for Medical Devices - Featured Image

Free Complaint Template for Medical Devices

One of the major post-market responsibilities of medical device companies is handling customer compl...
Free Template: Nonconformance Process for your Medical Device - Featured Image

Free Template: Nonconformance Process for your Medical Device

Eventually, every quality professional is going to have to deal with nonconformance. In the medical ...
Greenlight Guru Introduces Quality Event Automation to Advance Efficiencies in the Management of Post-Market Quality Events - Featured Image

Greenlight Guru Introduces Quality Event Automation to Advance Efficiencies in the Management of Post-Market Quality Events

New capability automates the quality event process through customized templates that increase effici...
A Free CAPA Template for the Medical Device Industry - Featured Image

A Free CAPA Template for the Medical Device Industry

If you’re a medical device professional, you’ve likely heard the acronym “CAPA” before. For those wh...
23 Must-haves for your Product Requirements Document (Free Checklist + Guide) - Featured Image

23 Must-haves for your Product Requirements Document (Free Checklist + Guide)

With the rapidly accelerating pace of innovation in the medical device arena, the procedures and pra...
How to Write a Nonconformance Report - Featured Image

How to Write a Nonconformance Report

Nonconformance is a word no quality manager wants to hear.
What is a Multiple Function Device? - Featured Image

What is a Multiple Function Device?

What is a multiple function device? From a high level, it’s a product with at least one portion that...

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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