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Becoming Compliant with the MDRs: A Real-Life Case Study

Available On Demand Until January 15, 2020

The new Medical Device Regulations (MDRs) become enforceable May 2022. After that, all new devices set for market in the European market will have to demonstrate compliance with ISO 10993, even if the device has been on the market for years.

This presentation will walk through a real-life example of bringing a device that has been on the market in Europe into compliance with the ISO 10993 and the new MDRs.


Matthew R Jorgensen, PhD, Senior Extractables and Leachables Expert, Nelson Labs

Dr. Jorgensen is a seasoned scientist with a diverse background in chemistry and material sciences. Currently he focuses his efforts on using extractable and leachable chemistry in the evaluation of medical device biocompatibility. His academic work focused on synthesis and characterization of biomimetic materials, fabrication of microscale devices, and photonics. He has a professional interest in both technical and popular science writing, which has produced over 30 peer reviewed scientific articles and hundreds of blog articles.

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