Preparing Your Company for the Medical Device Single Audit Program (MDSAP)

Tue. February 5| 4:45 PM - 5:30 PM | 210D

Show: MD&M West 2019

Track: MD&M West: Regulatory & Quality Update

Badge Type: Paid

The MDSAP auditing program has recently seen major spikes in the total number of participating manufacturer sites, which could be explained by Health Canada's requirement that companies now be compliant. This requirement led to some scrambling among device makers to schedule audits in time, and despite the many tweaks implemented over the past year to facilitate the transition, many issues facing small to medium-size firms remain. This session will shed some light on the pilot program and explain how manufacturers can use it to their advantage.

Topics 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 being addressed
  • Effectively standardizing activities within the quality system to address different requirements


Geetha Rao

Geetha Rao


Springborne Life Sciences

Role: Speaker