The english speaking intensiv seminar "Manager Regulatory Affairs – TÜV" covers the “Specialist Management Systems –TÜV" and "Specialist Technical Documentation – TÜV" qualifications. You prove your expertise in medical device law and management systems and your are able to monitor the approval of medical devices in the European Economic Area. You are familiar with the various requirements for technical documentation in the individual risk classes. You know the regulatory requirements for clinical evaluation and risk management in accordance with the EN ISO 14971:2012 standard and how to document and monitor processes. Within the scope of regulatory affairs, you are capable of taking responsibility for the registration of your medical devices in the EU.
- Medical Devices Law, foundation course
- MDD, relevant standards, EC directives, MEDDEV
- Current legal framework for medical devices in the EU
- Technical documentation
- Conformity assessment procedures, 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 analyses
- Workshop on practical implementation
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.