The workshop conveys basics of risk management for medical devices and the procedures for performing risk analyses in accordance with legal and normative requirements.
It is based on the EU regulation 2017/745 and the EN ISO 14971 standard. The workshop details drawing up and implementing a comprehensive risk management process.
- Legal requirements for risk management
- Structure and content of EN ISO 14971
- Structure of the risk management file
- Preparing a risk management plan
- Hazards and their assessment
- Risk analysis and mitigation
- Risk management report
- Risk management during the product life cycle
- Integration into the quality management system