Module 1 covers the "Specialist Management Systems –TÜV" and "Specialist Technical Documentation – TÜV" qualifications. Attendees acquire the "Manager Regulatory Affairs – TÜV" qualification certificate. You prove your expertise in medical device law and management systems and are able to monitor the approval of medical devices in the European Economic Area. You know the regulatory requirements for clinical evaluation and risk management in accordance with the EN ISO 14971:2012 standard and know how to document and monitor processes.
Module 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.
Module 1: "Specialist Technical Documentation – TÜV" und "Specialist Management Systems – TÜV" (6 days)
- Medical Devices Law, foundation course
- MDD, relevant standards, EC directives, MEDDEV
- Technical documentation
- Conformity assessment, technical documentation
- Management systems for manufacturers
- Structure, application of EN ISO 13485:2016
- Clinical evaluation of medical devices
- Clinical investigation, clinical investigation plan, ethics commission
- Risk management and risk analysis for medical devices
- Contents of the EN ISO 14971:2012 standard, risk analysis
- Workshop on practical implementation
Module 2: "Manager Regulatory Affairs International – TÜV" (5 days)
- Registration of medical devices outside the EU
- Registration of medical devices in Eastern Europe and 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 comparison to Europe
- Relevance of US FDA requirements, special FDA regulations
Who should attend
- Newcomers in the medical device industry
- Expert and executive personnel 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 TÜV SÜD Academy
Die Inhalte des Seminars entsprechen dem aktuellen Stand der Revision/Harmonisierung. Das Seminar wird im Rahmen der TÜV SÜD Sommer- und Winterakademie in deutscher und englischer Sprache angeboten.
TÜV SÜD Academy 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.