Hardware Podcasts

054 - "EUDAMED" with Richard Houlihan

Let's Combinate · 12 Oct 2022 · 28m

What this episode covers

Richard Houlihan, CEO of Eirmed, discusses the history, structure, and compliance requirements of EUDAMED, the European Commission's medical device database. He details the system's six modules, highlighting the complexity of the clinical investigations module and the shift from private competent authority access to public transparency for device data. Houlihan explains the legal obligations for economic operators, including manufacturers, authorized representatives, and importers, emphasizing that EUDAMED is a mandatory cost of doing business in Europe with strict data validation rules.

Most relevant to

early-stage companies

Topics

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Companies
Eumed
Also
EUDAMED, European Commission, FDA

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