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2018-12-01
2018-12-19
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Webinar: EU Medical Device Regulation Overview

Speaker: Yu Zhao, Director, Global Regulatory Affairs, Medtronic

Time: Dec 19, 2018 (Wednesday), 9 - 10 PM, EST
Title sponsor: Luye Pharma Group, Ltd.

The European Union Regulation on Medical Devices (MDR) and the Regulation on In-Vitro Diagnostic Medical Devices (IVDR) went into effect in May of 2017, effectively replacing decades-old Medical Device Directive (93/42/EEC), the Active Implantable Medical Device Directive (90/385/EEC) and the In-Vitro Diagnostic Medical Device Directive (98/79/EC). The EU MDR/IVDR will create new quality and transparency requirements for medical device manufactured or imported to the EU. The new regulations represent huge challenges and opportunities for medical device manufacturers on bringing innovations to the EU market while improving patient outcomes. This webinar will provide high-level overview of the EU MDR, and the key changes made and their impacts.

Yu Zhao is the Director of Global Regulatory Affairs at Medtronic Diabetes. He has worked in the regulated industries for over 20 years in various professional and leadership roles in areas of engineering, operations and regulatory affairs, with last 14+ years with Medtronic. In his current role, Yu oversees pre- and post-market regulatory activities, international regulatory, regulatory compliance for Diabetes Service and Solutions business unit. Previously, Yu served in other Medtronic business units under Diabetes and Neuromodulations, responsible for bringing artificial pancreas device system (with insulin pump and continuous glucose monitor), implantable devices such as deep brain stimulation, spinal cord stimulation and implantable drug pumps to global markets. Yu has had extensive experiences working with U.S. FDA, China FDA, EU notified bodies and other global regulatory agencies. Yu holds a B.S. in Electrical Engineering from Zhejiang University, China, an MBA and a Master of Science from Washington University, St. Louis, United States.

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