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5 Tips for Medical Device Registration across Global Markets - Featured Image

5 Tips for Medical Device Registration across Global Markets

You have compiled all of the necessary documentation for your regulatory submission, submitted it to...
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...
What are the Changes to ISO 14971:2019 & TR 24971? - Featured Image

What are the Changes to ISO 14971:2019 & TR 24971?

Proper risk management is a key process throughout the entire life cycle of a medical device. This i...
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...
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...
EU MDR: Not All Doom and Gloom - Featured Image

EU MDR: Not All Doom and Gloom

Feeling gloom, doom, concern, and fear about the new European Union Medical Device Regulation (EU MD...
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The 2003 edition of ISO 13485 has now been withdrawn and fully replaced by the 2016 edition.[i]  As ...
Medical Device QMS Changes: How to Manage Changes Regarding EU MDR, IVDR & ISO 13485:2016 - Featured Image

Medical Device QMS Changes: How to Manage Changes Regarding EU MDR, IVDR & ISO 13485:2016

One thing that seems to be constant in the global medical device industry is change.
EU MDR and IVDR Are Live – Here Are Some Important Items You Should Know! - Featured Image

EU MDR and IVDR Are Live – Here Are Some Important Items You Should Know!

After almost 10 years of careful deliberations, the new EU regulations on medical devices finally ha...

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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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