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
In August 2018, I did a survey of some European Authorized Representatives via email.
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.
Want a good career with lots of job security? Learn how to perform clinical evaluations or run clinical investigations.