Trying to understand the “state of the art” in medical device risk management? This diagram attempts to distinguish between ISO and European requirements.
Tag Archives: medical devices
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 they will publish ISO / IEC and CEN / CENELEC standards with the “EVS-” prefix added to the front of the designation See examples below. Example A – ISO Standards (the standard identification number 12345 and the EuroContinue reading “ISO IEC EN Standards Hacks, Tips, Tricks”
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.
Risk flowchart you won’t find in EN ISO 14971:2012
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 WRONG.
What standards apply to my medical device?
This should be one of the first questions asked during the medical device development process.
Europe MDR General Safety & Performance Requirements vs. MDD Essential Requirements
The Annex I “Essential Requirements” of the European medical device directives have been supercharged and reincarnated
Quality System Process Risk Management (ISO 13485:2016)
ISO 13485:2016 has a broader view of risk management than in the past.
Europe Medical Devices Regulation (MDR) 2017/745 with Table of Contents and Bookmarks
Did you notice that the published regulation does not have a table of contents or bookmarks?
