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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)

Complete Guide to Bringing a Medical Device to Market - Featured Image

Complete Guide to Bringing a Medical Device to Market

Why the FDA Pre-Submission is an Underutilized Tool - Featured Image

Why the FDA Pre-Submission is an Underutilized Tool

“I wish there was a way for the FDA to give me a feedback about my medical device, prior to submissi...
13 Tips For Audit Etiquette Every Medical Device Company Should Know - Featured Image

13 Tips For Audit Etiquette Every Medical Device Company Should Know

I love audits. Seriously! It is a hybrid experience, like a kindergarten show-and-tell with a classi...
6 Most Common Mistakes When Implementing ISO 13485 - Featured Image

6 Most Common Mistakes When Implementing ISO 13485

Companies must establish and maintain a quality management system in order to ensure they are produc...
8 Most Common Mistakes to Avoid with 21 CFR Part 820 - Featured Image

8 Most Common Mistakes to Avoid with 21 CFR Part 820

Medical device companies selling or planning to sell into the US market should be familiar with FDA'...
5 Most Common Mistakes Made When Implementing ISO 14971 - Featured Image

5 Most Common Mistakes Made When Implementing ISO 14971

ISO 14971 is a descriptive regulatory standard that provides guidance for how to apply risk manageme...
ISO 13485 Medical Device Quality System Standard and Other Regulatory Conundrums - Featured Image

ISO 13485 Medical Device Quality System Standard and Other Regulatory Conundrums

The 2003 edition of ISO 13485 has now been withdrawn and fully replaced by the 2016 edition.[i]  As ...
Why Document Control Matters To Medical Device Companies - Featured Image

Why Document Control Matters To Medical Device Companies

As medical device professionals, we share a common goal of producing safe and effective medical devi...
What to Expect During an FDA QSIT Inspection - Featured Image

What to Expect During an FDA QSIT Inspection

You arrive at work one morning and there are FDA inspectors sitting in your waiting area. If you are...

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