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Learn about the roles, responsibilities and legal requirements of a U.S. FDA Agent. Expect to read about compliance implications and common misconceptions.
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Learn where Medical Device Start-Ups go wrong and how to avoid these pitfalls.
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Learn about the UKRP appointment and registration process, the importance of proper documentation, and manufacturers' obligations from a UKRP perspective.
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Join Oliver Schaer and Bingshuo Li on 21-23 April at DMEA 2026 in Berlin and explore practical insights on Digital Health.
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Join industry leaders, regulatory professionals and Qserve Expert Gert Bos at MedCon 2026 in Columbus, Ohio on Apil 22-24.
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The transition to IVDR is entering its final phase, and the clock is ticking for Class C IVD manufacturers. Under the IVDR, Class C devices now require assessment by a notified body.