“U” is for unannounced audits – what’s up with those?

I visited the RAPS Regulatory Convergence conference in Seattle, which provides for a very nice opportunity to catch up with the European medical devices crowd that had gathered in numbers to explain the current changes in EU medical devices law to the US audience and to each other. Apart from the ever charming and authoritative Ms Minor of the European Commission who provided an excellent overview of the current state of the EU medical devices revision, there was a very interesting session on unannounce [...] « Read the rest of this article on medicaldeviceslegal »