Content
The seminar teaches the basics of risk management for medical devices and the procedure for carrying out risk analyzes in accordance with legal requirements. The basis is the currently valid standard ISO 14971. The seminar provides an overview of the relevant steps for risk assessment and minimization. The contents and requirements of ISO 14971 are taught as well as the purpose and process of a risk analysis. Examples from practice illustrate the implementation.
Topic overview
- Overview of the regulatory requirements for the safety and risk minimization of medical devices
- Structure and structure of ISO 14971
- Establishment of a risk management file
- Hazards and their assessment, risk assessment
- Procedure for the risk analysis (implementation, form, report, documentation requirements)
- Risk minimization
- Risk assessment during the various product life cycles
- Practical examples
target group
Medical device manufacturers as well as QM managers, regulatory affairs, product managers, developers, production planning and safety officers, employees from purchasing and supplier support as well as design transfer.
Prior knowledge
Basics in the regulatory requirements for the development of medical devices are recommended.
Funding opportunity
ESF funding is possible. Further information can be viewed here .
Early bird discount
If you register up to 3 weeks before the start of the seminar, you will receive an early bird discount of 10 percent.
KONTAKT:
TuttlingenTuttlingen & Online
