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Webinars & Events >> Webinars & Seminars >> CE/MDR versus FDA submission: Biocompatibility requirements. Differences, Challenges & pitfalls

CE/MDR versus FDA submission: Biocompatibility requirements. Differences, Challenges & pitfalls

In May 2021 the Medical Device Regulation (MDR) came into effect and the U.S. Food and Drug Administration (FDA) published the updated guidance for biocompatibility assessment of medical devices in September 2023.

In this webinar, we will explore the essential aspects of biocompatibility assessment and especially the differences to meet regulatory compliance in Europe and for the US FDA.

Our speaker will provide valuable insights and practical guidance to help you ensure that your medical devices meet the necessary biocompatibility standards for market approval.

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