The english speaking intensiv seminar Manager Regulatory Affairs International – TÜV (Modul 2) qualifies you to speed up approvals on the key international markets. You know the various framework conditions and approval requirements in the key target markets. Within the scope of regulatory affairs, you can take responsibility for the global registration of your medical devices.
- Registration of medical devices outside the EU
- Registration of medical devices in Eastern Europe
- Registration of medical devices in the Middle and Far East
- Registration of medical devices in the USA
- US market for medical devices, FDA and 510(k) requirements
- US FDA QM requirements in accordance with 21 CFR 820 QSReg/GMP in comparision to Europe
- Relevance of US FDA requirements, special FDA regulations
Who should attend
- Newcomers in the medical device industry
- Expert and executive personnel that want to update their knowledge
- Personnel in charge of regulatory affairs
- Personnel in quality management
- Engineers in the medical device industry
- Consultants in the medical device industry
Certificate Manager Regulatory Affairs – TÜV
Certificate TÜV SÜD Academy
We recommend to attend Manager Regulatory Affairs – TÜV (Modul 1), intensive seminar in advance
TÜV SÜD Akademie senior expert trainers
- Obtain high-class training and qualify as Manager Regulatory Affairs International – TÜV in a very short time.
- Gain an overview of all important parameters in the medical device industry.
- Familiarise yourself with worldwide registration requirements for medical devices.