Trying to understand the “state of the art” in medical device risk management? This diagram attempts to distinguish between ISO and European requirements.
So many people ask me for Notified Body (NB) selection advice that I decided to get a little organized.
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.
The Annex I “Essential Requirements” of the European medical device directives have been supercharged and reincarnated
Did you notice that the published regulation does not have a table of contents or bookmarks?