Trying to understand the “state of the art” in medical device risk management? This diagram attempts to distinguish between ISO and European requirements.
Sane people use their Saturday mornings for household tasks, lawn-mowing or catching up on sleep. Not me! I have a weekly appointment with myself that
Thank you, NAMSA, for preparing this amazing document!
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