Trying to understand the “state of the art” in medical device risk management? This diagram attempts to distinguish between ISO and European requirements.
Tag: medical devices
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
ISO IEC EN Standards Hacks, Tips, Tricks
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
Sam’s List of FDA Registered Contract Manufacturers & Sterilizers in SF Bay Area
Think global, buy local…and local for me is the San Francisco, California USA area.
Notified Body Selection Guide
So many people ask me for Notified Body (NB) selection advice that I decided to get a little organized.
Europe Clinical Evaluation Guidelines SmackDown
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.