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.
Monthly Archives: July 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.
