The Medical Device Single Audit Program (MDSAP) enables medical device manufacturers to comply with the regulatory requirements of multiple countries through a single audit, optimizing resources and ensuring international compliance.

This course provides you with the tools necessary to understand, implement, and maintain a management system aligned with MDSAP requirements, strengthening the quality, safety, and traceability of medical devices.

Main Topics:

✅ Structure and scope of the MDSAP program

✅ Regulatory requirements of participating countries (USA, Canada, Brazil, Japan, and Australia)

✅ MDSAP audit process and focus areas

✅ Integration with ISO 13485 and continuous system improvement

Aimed at:

✔️ Medical device manufacturers and suppliers

✔️ Quality, compliance, and regulatory affairs officers

✔️ Consultants, auditors, and professionals in the medical-industrial sector