Trying to understand the “state of the art” in medical device risk management? This diagram attempts to distinguish between ISO and European requirements.
In August 2018, I did a survey of some European Authorized Representatives via email.
So many people ask me for Notified Body (NB) selection advice that I decided to get a little organized.
Want a good career with lots of job security? Learn how to perform clinical evaluations or run clinical investigations.
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 WRONG.
The Annex I “Essential Requirements” of the European medical device directives have been supercharged and reincarnated
Did you notice that the published regulation does not have a table of contents or 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!