In her latest article for IPI, Qinecsa President, Humaira Qureshi discussed the practical challenges of integrating medical devices into pharmacovigilance portfolios, the obligations of device manufacturers, how to navigate the European Medical Device Regulation, maintaining effective post-market surveillance and managing the life cycle of a medical device.
Understanding medical device regulations is essential for pharmacovigilance professionals seeking to master device vigilance compliance and operational excellence. This article delves into the essentials necessary to navigate the complex EU device vigilance regulatory landscape and considers differences in drug and device surveillance requirements to help pharma partners confidently adapt departments to the changes.
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