Webinar: The requirements of the Medical Device Single Audit Program (MDSAP)

The Medical Device Single Audit Program (MDSAP) was developed by the International Medical Device Regulators Forum (IMDRF). It allows medical device manufacturers to demonstrate that their quality management systems comply with regulatory requirements across multiple countries.

Through a single audit, manufacturers can address requirements from five participating countries: Australia, Brazil, Canada, Japan, and the United States. Regulatory authorities use MDSAP audit results in their medical device authorization processes. This approach can reduce the number of separate audits and help manufacturers access important international markets.

In this webinar, you will learn:

• What MDSAP is and its main objectives
• The benefits of MDSAP compared with separate national audits or inspections
• Which countries and regulatory authorities participate in MDSAP
• Which regulatory requirements are covered during an MDSAP audit
• How nonconformities are graded
• Which documents manufacturers receive following an MDSAP audit
• How regulatory authorities use MDSAP audit results

• Introduction to MDSAP
• MDSAP history and benefits across participating regulatory authorities
• MDSAP certification requirements and audit process
• Questions and Answers (Q&A)
• Closing Remarks 

• Medical device manufacturers 
• Quality management and quality assurance professionals
• Regulatory affairs professionals
• Medical Device Compliance and certification teams
• Professionals preparing for MDSAP audits