Regulatory Standards and Risk Management in Medical Devices Webinar

Recorded: April 21, 2016



Moderator
Ben Noe
R&D Project Manager, Medtronic
BMES Industry Committee Chair

Speakers
George Serafin
National Managing Director, Deloitte and Touche LLP  

Mutahar Shamsi
Specialist Leader, Deloitte and Touche LLP

Nicole Schumacher
Senior Manager, Deloitte and Touche LLP

The speakers highlight their unique career paths to industry and provide an overview of the quality and regulatory trends within the medical devices industry, covering the basic standards and processes and providing concrete examples for each. Topics presented include:
 
  • Medical device regulations (Class I, II, and III)
  • Other relevant regulations including IEC, ISO, EU harmonized, wireless standards
  • Risk management process for medical devices
  • Quality control systems and techniques

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This copyrighted webinar is produced by the Biomedical Engineering Society (BMES) for the sole use of its membership. Any rebroadcast or retransmission without the written consent of BMES is prohibited.

©BMES 2016