The MDSAP audit model was developed as part of an initiative of the International Medical Device Regulators Forum (IMDRF). MDSAP describes a standard procedure for carrying out regulatory quality management audits for medical device manufacturers. MDSAP audits can only be carried out by authorised auditing organisations. After January 1st 2019, when it comes to applying for and renewing Medical Device Licenses for medical devices that fall into classes II, III and IV Health Canada will only accept certificates that have been carried out according to MDSAP. You will learn how to correctly interpret the audit model and you will learn about the different aspect that the manufacturer needs to pay attention to when preparing for an MDSAP audit.
- Why MDSAP? Benefits for medical device manufacturers
- Introducing the MDSAP audit model
- New features included in the MDSAP audit model:
- Ranking of non-conformities
- Calculating the audit duration
- Country specific requirements
- Preparing for a MDSAP audit
Who should attend
- Medical device manufacturers, exporters
- Employee Quality Management
- Employee Regulatory Affairs
- External and internal auditors
Certificate of attendance TÜV SÜD Akademie
The seminar hand-out is partly english.
TÜV SÜD Akademie senior expert trainers
- You will learn how participating in MDSAP can enable your medical devices to gain efficient market entry.
- You can identify non-conformances in your quality management system more quickly and easily.
- You will learn how to effectively prepare for an MDSAP audit.