Clinical Evaluation Literature Search

The basis of your device CERs is Literature Search. If you're in charge of compliance for a number of goods, you're well aware that EU MDR presents a significant challenge to your team and current timeframes. If you're a smaller manufacturer, you're probably just dealing with one or two people who are responsible for [...]

By |2021-12-20T12:09:00+00:00September 2nd, 2021|UK CA|0 Comments

Eudamed Actor Registration

EUDAMED is the European Medical Device Databank. It's a safe, web-based portal that serves as a hub for information exchange between national authorities and the European Commission. The portal is not accessible to the public. EUDAMED came into force in May 2011 intending to improve market surveillance and transparency in the setup of medical [...]

By |2022-05-14T10:00:10+00:00July 2nd, 2021|EU CE|0 Comments
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