content
The seminar conveys 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 risk minimization. The contents and requirements of ISO 14971 are conveyed, as is the purpose and process of a risk analysis. Practical examples 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
- Creation of a risk management file
- Hazards and their assessment, risk assessment
- Procedure for 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 those responsible for QM, regulatory affairs, product managers, developers, production planning and safety officers, employees from purchasing and supplier support as well as design transfer.
previous knowledge
Basics in the regulatory requirements for the development of medical devices are recommended.
KONTAKT:
Max-Planck-Straße 17, TuttlingenBeruflichen Bildungsstätte Tuttlingen & Online
