The english speaking intensive seminar „Manager Regulatory Affairs – TÜV“ includes the certificate as „Manager Regulatory Affairs – TÜV“. You demonstrate your competence in the areas of medical device law (MDR) and management systems (ISO 13485) and are able to carry out approvals of medical devices in the European Economic Area. You are familiar with the regulatory requirements for clinical evaluation, risk management according to ISO 14971 and the contents of technical documentation.
- Basic course in medical device law – regulatory framework according to MDR
- Current regulatory framework for medical devices in Europe (MDR)
- Basic safety and performance requirements, CE marking
- Technical Documentation
- Conformity assessment procedure
- Management systems for manufacturers
- Construction, application of ISO 13485:2016
- Clinical evaluation of medical devices
- Requirements and their implementation
- Contents of a Clinical Evaluation Report
- Risk management and risk analysis for medical devices
- Contents of ISO 14971, risk analyses
- Practical implementation workshop
Who should attend
- Newcomers in the medical device industry
- Expert and executive personnel seeking 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 of TÜV SÜD Akademie
This course addresses internationally valid standards and can also be held abroad.
TÜV SÜD Academy senior expert trainers
- Complete this premium-quality qualification in the shortest possible time.
- Understand the registration requirements in the European Union.
- Gain an overview of the most important parameters in the medical device industry.