"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…


Some important practical points for ISO 14155 compliant clinical trial agreements in the EU, part 1

In my day-to-day legal practice I see a number of points related to clinical investigation that seem to return and repeat all the time and thought it a good idea to share…


Outsourced clinical investigation: legal aspects

Last Wednesday 13 April I spoke at Informa’s 6th Annual Clinical Evaluations and Investigations for Medical Devices conference about legal aspects of outsourced clinical investigation in the medical devices industry. Proceeding from showing…


Software design for medical devices

I just returned from an interesting conference in Munich about software design for medical devices. I had the privilege to present on legal issues and some regulatory issues related to software and…


Software as medical device – regulatory requirements, product liability

I attended an interesting seminar today about software as medical device organised by NEN, the Dutch standardisation institute. Speakers at the seminar highlighted the different views on this subject from the perspective…

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