RAPS Vancouver Chapter: The Medical Device Single Audit Program (MDSAP): What Does it Mean for Devic

Wednesday, October 18, 2017, 5:30 PM - 8:00 PM PT

The RAPS Vancouver Chapter invites you to come engage with colleagues from your local regulatory communities for an interactive session on the Medical Device Single Audit Program (MDSAP). The MDSAP allows medical device manufacturers to be audited once for compliance to the regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States. The program’s main mission is to “…jointly leverage regulatory resources to manage an efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturers.”

This presentation will discuss the current state and implementation of the MDSAP. As one of the first auditing organizations performing MDSAP audits, Intertek will share their experiences with the program and what it's implementation means for medical device manufacturers.

Topics to be covered include:

  • The current state of MDSAP (Upsides, Pitfalls and Observations)
  • Common concerns and misunderstandings about transition
  • The prospective future and where to find resources

This program is brought to you by the RAPS Vancouver Chapter and is intended to encourage knowledge sharing and community development among regulatory professionals. Dinner will be provided. RAC holders may claim two RAC recertification credits.