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Erik Vollebregt
In a previous post I gave a number of practical tips for drafting ISO 14155 clinical trial agreements. In this post I will give another few. Additional points will surely come to…
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Erik Vollebregt
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…
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Erik Vollebregt
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…
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Erik Vollebregt
ISO 14155, who in medical devices is not familiar with that standard with respect to clinical investigation of medical devices for human subjects? Not that long after the EU had harmonised the…