BSI white paper on EU medical devices revision

Are you still with me on where we are with the EU revision of medical devices and IVD legislation? If you are, you have strong tolerances for fast moving complexity – congratulations!…


What to expect in the new EU in vitro diagnostics regulation?

Our seminar on IVD legal and regulatory issues of 12 september was a big succes. We had the passionate story of Henk ViĆ«tor about Skyline Diagnostics’ efforts to bring its products to…


Improving implementation: the Code for Notified Bodies

It’s finally public: the Code of Conduct for Notified Bodies under Directives 90/385/EEC and 93/42/EEC “Improving implementation of the European CE certification of medical devices through harmonization of quality and competence of…

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