This two-day Medical Device Single Audit Program (MDSAP) Implementation course is for medical device manufacturers who want to be audited only once for compliance with the standard and regulatory requirements of multiple regulatory authorities.
This course provides management system practitioners with the knowledge and skills required to implement an ISO 13485:2016 Quality Management System (QMS) which meets the regulatory requirements of different medical device markets: Australia, Brazil, Canada, Japan and the United States.
Who should attend?
- Professionals involved with an ISO 13485:2016 management system, plan to continue placing devices on the market in Australia, Brazil, Canada, Japan and the United States
- Organisations to maintain the effectiveness of QMS compliance based on ISO 13485:2016 whilst adopting the relevant jurisdiction requirements in the countries engaged in the MDSAP
- Individuals who want to learn how MDSAP differs from the traditional ISO 13485:2016 audit, through its regulatory audit approach, the grading of nonconformities and handling of the audit report
- An organisation who wants to prepare for an upcoming audit ahead of the deadline.
What will you learn?
- What is the Medical Device Single Audit Program (MDSAP) and why was it developed
- What regulatory authorities participate in the MDSAP program
- The fundamentals behind the MDSAP audit model and companion guidance
- The structure and scope of the MDSAP audit program, audit processes and their interrelationships
- The differences between MDSAP and other QMS audits, enhancing your existing auditing skills and be prepared to support an efficient MDSAP audit
- To identify MDSAP documentation and use correct jurisdictional terminology including reporting and nonconformity grading
- To prepare for the MDSAP audit time and use of the audit reports.
What do you need to prepare?
Basic knowledge of ISO 13485:2016 and/or EN ISO 13485:2016 fundamentals.
- Training course materials
- Lunch and refreshments for public attendees only
- Certificate of attendance.