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

The Medical Device Single Audit Program (MDSAP), developed by the International Medical Device Regulators Forum (IMDRF), enables medical device manufacturers to demonstrate that their quality management system meets the regulatory requirements of multiple countries.

A single audit can address the requirements of several MDSAP-participating countries, including Australia, Brazil, Canada, Japan and the United States. The regulatory authorities in these countries, along with several others, accept the results of MDSAP audits as part of their medical device marketing authorization processes. MDSAP offers medical device manufacturers the opportunity to reduce audit burden and facilitate access to key international markets.

• What are MDSAP and its objectives
• The advantages of MDSAP over individual national audits or inspections
• Which countries and authorities participate in MDSAP
• The audit requirements covered
• Nonconformity grading specifics
• What output documents you will receive following an MDSAP audit
• How authorities utilize the audit outputs

The webinar is intended for:

• Medical device manufacturers who market their products in MDSAP-participating countries or plan to do so
• Companies dealing with MDSAP for the first time
• Organizations preparing for an upcoming MDSAP audit