MDSAP Overview Training

DQS is organizing 16 hours of an online training program on MDSAP (Medical Device Single Audit Program) Overview.

The Medical Device Single Audit Program (MDSAP) offers the opportunity to demonstrate compliance with the regulatory requirements of up to five participating countries in the course of a certification process: Australia, Brazil, Japan, Canada and the USA. The advantages of the program are not only the recognition of the results in the registration of medical devices but also the reduction of on-site inspections by the participating authorities.

• Fundamentals of MDSAP
• Structure of MDSAP
• Requirements under MDSAP
• Audit expectations and evidence
• Understanding of the Subsystem and task structure
• The difference in approach for MDSAP and other QMS Audits
• Understanding of Nonconformity grading and its implications
• Implementation expectations from the manufacturer
• MDSAP audit conclusions
• Post audit activities