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


Marcelo Trevino (Senior Vice President of Regulatory Affairs and Quality, Applied Medical)


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

Date: Wednesday, February 7

Time: 1:15pm - 2:30pm

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

Conference Track: MD&M: Regulatory & Quality Update

Vault 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