February 6-8, 2018Anaheim Convention CenterAnaheim, CA

Use the scheduling tool below to browse all the available sessions, speakers and topics at this year's event. Find the content and sessions to fit all of your educational needs and ensure you get the most out of your time at the show.

Panel: FDA Case for Quality Update

  • Frank Pokrop (Director, Quality and Regulatory Affairs, BD)
Location: 210D
Pass Type: Conference (Paid) - Get your pass now!
Conference Track: MD&M: Regulatory & Quality Update
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