Medical Device Single Audit Program (MDSAP) – Requirements and Preparation - English
The Medical Device Single Audit Program (MDSAP) audit model was developed at the initiative of the International Medical Device Regulators Forum (IMDRF). MDSAP describes a unified approach for regulatory quality management system audits of medical device manufacturers. Only accredited auditing organizations may conduct MDSAP audits. The program involves Australia, Brazil, Canada, Japan, and the USA.
In this course, you will learn how to correctly interpret the MDSAP audit approach and understand which aspects manufacturers must consider to successfully prepare for an MDSAP audit.
Classification of nonconformities Audit time calculation Country-specific requirements
Medical device manufacturers and exporters, quality management staff, regulatory affairs personnel, internal and external auditors.
- This seminar is part of a modular training program. After successful completion of the advanced modules, you may earn the recognized qualification:
Manager Regulatory Affairs international – TÜV - Due to the international topic, seminar materials are provided in English.
English
Certificate of participation issued by TÜV SÜD Academy
This training is being operated by TÜV SÜD Akademie GmbH in Germany. The General Terms and Conditions as well as the Privacy Notice of TÜV SÜD Akademie GmbH apply. In case of any questions, do not hesitate to contact us.