Manufacturing Product Quality Excellence: FDA and Edwards Lifesciences Collaboration

On-Demand Webinar | 75 minutes

Learn how the FDA's quality programs are driving change for the future of medical device regulatory practices.

Presenters: Jason Spiegler, Senior Director Industry Portfolio Development, Siemens PLM Software - Moderator Francisco (Cisco) Vicenty, Program Manager Case for Quality, FDA - Office of Compliance Robert Becker, Senior Director of Quality, Edwards Lifesciences.

Discover what Edwards Lifesciences, a participant in the FDA’s Voluntary Medical Device Manufacturing and Product Quality Pilot program, has to say about the benefits of the collaboration. Learn how their digital transformation has changed the way they do business, and the impact it has had on driving quality and efficiency.


  • The need for product quality excellence (0:04:30)
  • The importance of collaborating with FDA (0:21:09)
  • The future is here: why to focus on digital manufacturing technologies (0:34:19)
  • The value of modern Manufacturing Execution Systems (0:50:29)
  • Question and Answer (1:02:43)

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