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: Making the Medical Device Single Audit Program (MDSAP) Work for You

Moderator:
  • Marcelo Trevino (Senior Vice President of Regulatory Affairs and Quality, Applied Medical)
Panelists:
  • Uwe Degenhardt (Director, Quality Compliance, Edwards Lifesciences)
  • Linnette Torres (Quality Director for Critical Care, Edwards Lifesciences)
  • Kristy Pollard (Senior Specialist for Quality Compliance in Auditing, Edwards Lifesciences)
  • Jessica Cho (Regulatory Affairs Manger, Applied Medical)
Location: 210D
Pass Type: Conference (Paid) - Get your pass now!
Conference Track: MD&M: Regulatory & Quality Update
Recording: TBD

The MDSAP develops a standardized, global approach to auditing and monitoring medical device manufacturing.
As the deadline to transition to the newer standard (particularly those with a CMDCAs registration) approaches, it’s not clear how device manufacturers can implement specific MDSAP requirements. This session will shed some light on the program and explain how manufacturers can use it to their advantage.

Topics to be covered include:

  • Status of MDSAP and findings from the program’s three-year pilot
  • Best practices from companies that have gone through an MDSAP audit
  • How key requirements, like audit preparation, are addressed
  • Effectively standardizing activities within the quality system to address different requirements