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7 FDA Pathways to Bring Your Medical Device to Market - Featured Image

7 FDA Pathways to Bring Your Medical Device to Market

Anyone reading this who is planning to launch a medical device in the U.S. has likely heard of the 5...
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...
7 Tips to Comply With FDA 21 CFR Part 11 - Featured Image

7 Tips to Comply With FDA 21 CFR Part 11

When it comes to regulatory compliance for medical device companies, there can be some confusion aro...
5 Steps for Getting your CE Marking with EU MDR Requirements - Featured Image

5 Steps for Getting your CE Marking with EU MDR Requirements

It has long been thought that the quickest path to market for medical device manufacturers is to acc...
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.
Navigating the Twists and Turns of Change Management for Medical Devices - Featured Image

Navigating the Twists and Turns of Change Management for Medical Devices

Change is constant… Especially in the medical device industry. Medical device change management can ...
What Is FDA's ASCA Pilot Program And How Does It Impact Medical Device Manufacturers? - Featured Image

What Is FDA's ASCA Pilot Program And How Does It Impact Medical Device Manufacturers?

FDA announced the anticipated 2020 launch of a new pilot program known as the Accreditation Scheme f...
8 Most Common Mistakes to Avoid with FDA 21 CFR Part 820 - Featured Image

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

If you’re a medical device company selling or planning to sell into the US market, you should be fam...
Tips for Success with IEC 60601 for Electrical Medical Devices - Featured Image

Tips for Success with IEC 60601 for Electrical Medical Devices

Does your company develop electrical medical devices? The standard IEC 60601 is different from other...
EU MDR Implementation Guide - Featured Image

EU MDR Implementation Guide

The European medical device industry will undergo significant changes as a result of the new medical...
The Ultimate Guide to the EU MDR General Safety and Performance Requirements (GSPR) - Featured Image

The Ultimate Guide to the EU MDR General Safety and Performance Requirements (GSPR)

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Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.

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