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Greenlight Guru Medical Device Blog

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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...
Medical Device Reporting (MDR): How to Take Advantage of Your Electronic Records - Featured Image

Medical Device Reporting (MDR): How to Take Advantage of Your Electronic Records

Some companies in the medical device industry show resistance to digital technology, preferring to u...
How to Plan and Control the Design of your Medical Device while Meeting Regulatory Expectations - Featured Image

How to Plan and Control the Design of your Medical Device while Meeting Regulatory Expectations

What is the expected process you should follow for your medical device design planning and controls?
The Beginner's Guide to Design Verification and Design Validation for Medical Devices - Featured Image

The Beginner's Guide to Design Verification and Design Validation for Medical Devices

When your medical device product development project gets to Design Verification and Design Validati...
Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): What's the Difference? - Featured Image

Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): What's the Difference?

The medical device industry has a lot of acronyms. 

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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