EN 14155

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Some important practical points for ISO 14155 compliant clinical trial agreements in the EU, part 2

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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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…

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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…

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ISO 14155:2011 is here: revised standards for medical devices clinical trials

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…

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