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Key Challenges for Risk Management in Medical Device Development - Featured Image

Key Challenges for Risk Management in Medical Device Development

If you’re in the business of developing medical devices, then risk and risk management become terms ...
5 Things the Medical Device Industry Should Expect in 2017 (And How You Can Prepare) - Featured Image

5 Things the Medical Device Industry Should Expect in 2017 (And How You Can Prepare)

What should the medical device industry expect in 2017? Great question. I’d like to share some of my...
A Review of the Most Important Medical Device Industry Topics in 2016 - Featured Image

A Review of the Most Important Medical Device Industry Topics in 2016

2016 was a very active and monumental year for the medical device industry. There were several impor...
Medical Device Risk – ISO 14971 Gets It Right - Featured Image

Medical Device Risk – ISO 14971 Gets It Right

Editor's note: This is a guest post authored by William Storage, VP LiveSky Inc., Visiting Scholar, ...
ISO 13485:2016 vs. ISO 13485:2003 vs. FDA 21 CFR Part 820: Comparing the Differences and Changes - Featured Image

ISO 13485:2016 vs. ISO 13485:2003 vs. FDA 21 CFR Part 820: Comparing the Differences and Changes

The publication and release of ISO 13485:2016 earlier this year is a significant movement for the me...
3 Common Misconceptions About Medical Device Packaging - Featured Image

3 Common Misconceptions About Medical Device Packaging

If you asked people what comes to mind when you say designing a medical device, you’re likely going ...
4 Lessons I Learned Going Through an FDA / ISO Audit for the First Time as an Engineer - Featured Image

4 Lessons I Learned Going Through an FDA / ISO Audit for the First Time as an Engineer

As an engineer, there’s not a lot that makes me nervous.   Going through an FDA / ISO audit?   That ...

The greenlight.guru Medical Device Blog

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