Want a good career with lots of job security? Learn how to perform clinical evaluations or run clinical investigations. … Clinical evaluation, investigation et al. in Europe MDR 2017/745
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. … Europe Clinical Evaluation Guidelines SmackDown
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. … Risk flowchart you won’t find in EN ISO 14971:2012
The Annex I “Essential Requirements” of the European medical device directives have been supercharged and reincarnated … EU MDR 2017/745 General Req vs. MDD 93/42/EEC Essential Req
Did you notice that the published regulation does not have a table of contents or bookmarks? … Europe Medical Devices Regulation (MDR) 2017/745 with Table of Contents and Bookmarks
Unfortunately, there is currently no centralized database to search Notified Bodies and their Client companies. Here are some ideas for how to go about this.
Notified Bodies are no longer fighting for your attention – you need to fight for their attention!