ISO 13485:2016 has a broader view of risk management than in the past.
Subtitle: Buying standards from the Estonian Centre for Standardisation (EVS) EVS is the national standards body in Estonia. Since Estonia is a member of the European Union
Think global, buy local…and local for me is the San Francisco, California USA area.
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.
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.