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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. 
Understanding Post-Market Surveillance Requirements for Medical Devices (US & EU Markets) - Featured Image

Understanding Post-Market Surveillance Requirements for Medical Devices (US & EU Markets)

As leaders of medical device companies, our goal is always to create devices that are safe and effec...
4 Major Reasons to Use Document Version Control Software for your Medical Device - Featured Image

4 Major Reasons to Use Document Version Control Software for your Medical Device

With the incredible volume of documentation required by the FDA and ISO, using a document control sy...
Medical Device Classification Guide - How To Determine Your Device Class - Featured Image

Medical Device Classification Guide - How To Determine Your Device Class

What I am about to share with you is a guide to medical device regulatory classification.
FDA 21 CFR Part 820: 8 Most Common Mistakes to Avoid - Featured Image

FDA 21 CFR Part 820: 8 Most Common Mistakes to Avoid

If you’re a medical device company selling or planning to sell into the US market, you should be fam...
Ultimate Guide to Agile Design and Development for Medical Devices - Featured Image

Ultimate Guide to Agile Design and Development for Medical Devices

                                Table of Contents   Overview - Agile Design and Development for Medi...
10 Essentials for Writing a Clear Product Requirements Document [Guide+Checklist] - Featured Image

10 Essentials for Writing a Clear Product Requirements Document [Guide+Checklist]

We distilled the insights from our research into this one guide + checklist that we hope will help a...

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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