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.
Does your ISO 13485:2016 upgrade project need a power-boost?
Want a good career with lots of job security? Learn how to perform clinical evaluations or run clinical investigations.
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.
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