This course will give an introduction into the Medical Device Single Audit Program (MDSAP). The introduction will give an overview about the program definition, the requirements for the quality management system, how a smart implementation of these requirements in the quality management system is possible and finally how the audit for five countries (Australia, Brazil, Canada, Japan, US) is working.
- What is the Medical Device Single Audit Program (MDSAP)?
- Which Companies must have MDSAP?
- Which Companies should have MDSAP?
- Which Companies should postpone MDSAP?
- What are the requirements of MDSAP?
- How to implement MDSAP in a smart way into a quality management system according ISO 13485, 21 CFR 820 (QSR) or any other regulatory framework?
- How the MDSAP-Audit is working?
- What is the difference between MDSAP and European Notified Body Audits?
Who will Benefit:
Life sciences companies who sell to Australia, Brazil, Canada, Japan or US will be benefited by attending this seminar:
- CEO and top executives
- Regulatory Affairs Managers
- Quality Managers
- Quality Representatives
- Other managers, who need to deal with regulatory or quality guidelines