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
This should be one of the first questions asked during the medical device development process.
The Annex I “Essential Requirements” of the European medical device directives have been supercharged and reincarnated
ISO 13485:2016 has a broader view of risk management than in the past.
Now is the time to get the 13485 monkey off your back.