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Post-Pandemic Readiness: Preparing for the Aftermath of COVID-19 on the Medical Device Industry - Featured Image

Post-Pandemic Readiness: Preparing for the Aftermath of COVID-19 on the Medical Device Industry

Are you prepared for the aftermath of the pandemic’s impact on the medical device industry? It may b...
How will Emergency Use Authorization (EUA) during Pandemic Influence Future FDA Policy Changes? - Featured Image

How will Emergency Use Authorization (EUA) during Pandemic Influence Future FDA Policy Changes?

Still seeking guidance to stay in the know when it comes to new and updated FDA requirements related...
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

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...
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 ...
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...
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...
Top 100 Medical Device Acronyms & Terminology You Need to Know - Featured Image

Top 100 Medical Device Acronyms & Terminology You Need to Know

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