Trying to understand the “state of the art” in medical device risk management? This diagram attempts to distinguish between ISO and European requirements.
Category: Europe
European Medical Device Standards: 2019-02-02
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
Looking for Medical Device EC-REP? (European Authorized Representative)
In August 2018, I did a survey of some European Authorized Representatives via email.
Europe MDR & IVDR on Steroids
Thank you, NAMSA, for preparing this amazing document!
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.