The Medical Device Single Audit Program (MDSAP) is an international initiative led by Regulatory Authorities (RA) to implement a program where Auditing Organizations (AO) can conduct a single audit of a medical device manufacturer that would be accepted by multiple regulators to address QMS/GMP requirements.
Health Canada has confirmed the requirement for medical device manufacturers to transition from CMDCAS to MDSAP to place devices into Canada. From January 1, 2019 Health Canada will only accept MDSAP for manufacturers who market their devices in Canada, hence, manufacturers will need to transition from ISO 13485 Certification issued by a CMDCAS recognized registrar to MDSAP Certification issued by an AO. BSI is recognized AO and is already conducting MDSAP audits.
This webinar will cover a summary of the Program, including what manufacturers can expect. However, this webinar will focus on the timelines and actions you need to take now to ensure continuity of supply for your products.
Patricia L. Murphy is the Global MDSAP Manager at BSI, with responsibility for all aspects of the Medical Device Single Audit Program. Patricia is responsible for maintaining BSI's leadership role in MDSAP, which will be accomplished by continuing to develop the competence of our assessment staff to meet the needs of our customers coupled with developing course materials for external delivery and participation in industry conferences.
Patty has worked in Medical Devices and Quality Assurance for over 25 years. Patty's most recent role has been as VP of Quality Assurance and Regulatory Affairs for a US based medical device manufacturer. Prior to that, she worked as Director of Quality Assurance, Principal Consultant and Certification Manager for an EU-based Certification Body.