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Panel: FDA Case for Quality Update


Frank Pokrop (Director, Quality and Regulatory Affairs, BD)


Francisco Vicentry (Program Manager – Case for Quality, FDA)

Stephanie Christopher (Program Director, Medical Device Innovation Consortium)

Rob Becker (Director, Quality, Edwards Lifesciences)

Garth Conrad (Vice President, Quality, CR Bard (now part of BD))

Location: 210D

Date: Tuesday, February 6

Time: 3:15pm - 4:45pm

Pass Type: Conference (Paid) - Get your pass now!

Conference Track: MD&M: Regulatory & Quality Update

Vault Recording: TBD

Medical device manufacturers can reduce costs and increase profits by focusing on quality measures during medical device design and production. This quality improvement approach pays dividends in customer satisfaction and provides significant competitive advantages. The Case for Quality program helps FDA and manufacturers understand and sustain the link between a quality improvement approach and the benefits such approach provides. In this session, CDRH representatives and other experts will discuss the Case for Quality program and how it can be used to manufacturers’ advantage.

Topics to be covered include:

  • Status update on initiatives like patient registries, structured product labeling, health outcomes, identifying risks, and mitigation strategies
  • Discussing the Quality Program Pilot Framework and how its modifications can decrease regulatory burden
  • Identifying risk and mitigation strategies