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Preparing for EU MDR - Featured Image

Preparing for EU MDR

Do you have a regulatory strategy to help your company prepare for the new European Medical Device R...
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)

Implementing Changes to SaMD under New EU MDR - Featured Image

Implementing Changes to SaMD under New EU MDR

Classification, qualification, and other changes to Software as a Medical Device (SaMD) under the ne...
Should you Swipe Right or Left on your Notified Body? - Featured Image

Should you Swipe Right or Left on your Notified Body?

How long have you been dating your Notified Body – “NB” for short? Is your eye beginning to wander? ...
The Essential Guide to Preparing your QMS for EU MDR - Featured Image

The Essential Guide to Preparing your QMS for EU MDR

How prepared is your quality management system for the new requirements of EU MDR for medical device...
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...
8 Questions About the European MDR Answered - Featured Image

8 Questions About the European MDR Answered

The European Medical Device Regulation (MDR) is a new set of regulations that governs the production...
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The 2003 edition of ISO 13485 has now been withdrawn and fully replaced by the 2016 edition.[i]  As ...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...
Clinical Evaluation Reports — Things You Should Know About the MEDDEV 2.7/1 Revision 4 - Featured Image

Clinical Evaluation Reports — Things You Should Know About the MEDDEV 2.7/1 Revision 4

European legislation requires medical device manufacturers to perform a conformity assessment of the...

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