Trying to understand the “state of the art” in medical device risk management? This diagram attempts to distinguish between ISO and European requirements.
Category Archives: Europe
Looking for Medical Device EC-REP? (European Authorized Representative)
In August 2018, I did a survey of some European Authorized Representatives via email.
Notified Body Selection Guide
So many people ask me for Notified Body (NB) selection advice that I decided to get a little organized.
Clinical evaluation & investigation in Europe MDR
Want a good career with lots of job security? Learn how to perform clinical evaluations or run clinical investigations.
Europe Clinical Evaluation Guidelines SmackDown
The European Commission’s medical device conniption reached a frenzied pitch with the release of the Medical Devices Regulation (MDR) 745/2017 in May 2017.
Risk flowchart you won’t find in EN ISO 14971:2012
If you are concerned about marketing your devices in Europe, don’t be fooled by the flowchart in the international version of ISO 14971:2007. It is WRONG.
Europe MDR General Safety & Performance Requirements vs. MDD Essential Requirements
The Annex I “Essential Requirements” of the European medical device directives have been supercharged and reincarnated
Europe Medical Devices Regulation (MDR) 2017/745 with Table of Contents and Bookmarks
Did you notice that the published regulation does not have a table of contents or bookmarks?
Notified Body Sleuthing
Unfortunately, there is currently no centralized database to search Notified Bodies and their Client companies. Here are some ideas for how to go about this.
Notified Body Selection Advice
Notified Bodies are no longer fighting for your attention – you need to fight for their attention!
