Wednesday, 16 May 2018
5:30–8:30 pm CDT
GE Healthcare Research Park
9900 West Innovation Drive
Wauwatosa, WI 53226
+1 800 437 1171
The Medical Device Single Audit Program (MDSAP) allows for a single audit covering ISO 13485 requirements and country-specific regulations for five participating countries: USA, Canada, Brazil, Australia and Japan. In Canada, MDSAP will replace the CMDCAS program and become a mandatory requirement for Class II, III and IV medical devices from 1 January 2019.
With over twenty years of regulatory affairs experience managing domestic and international regulatory submissions and global compliance activities, Pamela Swatkowski is a leader in regulatory affairs, quality assurance, business development, clinical and research and development in the medical device and IVD industry. In her role as director of global regulatory affairs for Abbott Molecular, she was part of the MDSAP Pilot Program and will share her experiences and lessons learned from that program.
Discussion topics will include:
- What is MDSAP?
- How does MDSAP work?
- How does MDSAP fit with other certifications?
- MDSAP Case Study and Experience in Pilot Program
The RAPS Wisconsin chapter invites you to join others from the local regulatory community to participate in this interactive activity. A meal will be available for all participants and RAC holders may claim two RAC recertification credits.
Pamela L. Swatkowski, regulatory and compliance expert, president, PLS Consulting, LLC
RAPS Members: $35