The Medical Device Single Audit Program (MDSAP) offers a way to streamline the pre- and post-market audit process required by medical device regulatory authorities in jurisdictions around the world. Under the MDSAP, a single audit performed by an authorized Auditing Organization (AO) can meet quality management system requirements in the US, Canada, Japan, Brazil, and Australia.
Health Canada will only accept MDSAP certificates starting in January 2019, which is motivating some companies to pursue MDSAP certification before the end of the year. But many companies are beginning to see it as a way to manage costs and ease market access. In this webinar, technical consultants Daryl Wisdahl and Ken Pilgrim discuss the benefits and potential challenges of MDSAP certification. You will learn:
- A brief history of the MDSAP
- MDSAP certification requirements and ISO 13485
- QMS requirements in MDSAP member markets
- An overview of the audit process
- Key factors to consider when defining the scope of your audit
- Our real-life observations from recent internal audits
- Potential challenges during the audit process
You will learn all this and more in this one-hour live webinar.
ABOUT THE PRESENTERS:
Ken Pilgrim is a Senior Technical Consultant for Emergo by UL and is located in Canada. With more than 20 years of experience in quality management, his expertise includes ISO 13485, MDSAP, and CMDR implementation and audits as well as medical device registration submissions in Canada, the EU, and US.
Daryl Wisdahl is a Senior Technical Consultant for Emergo by UL based in Seattle. Daryl has over 20 years of experience in the medical device industry, including Medical Device Licensing in Canada, QMS implementation and audits, and preparing US FDA 510(k) submissions.