Introduction Risk management for medical devices EN ISO 14971:2019
Introduction to the topic of risk management for medical devices (STTT-B6D-P1)
Short description
Training days:
1
Day
Description: - Why risk management
- Regulatory and normative requirements
- Risk management terms
- Risk policy, risk management plan
- Risk analysis
- Risk assessment
- Risk acceptance
- Risk control
- Residual risk and overall residual risk
- Production downstream phase
- Risk management report, risk management acts
Prior knowledge: Basics of risk management for medical devices
Note: Organisational requirements for the proper implementation of the training are agreed in advance
Number of participants: 5 to 12 Persons
Services: All participants receive: Handout (plus costs for in-house) and certificate of attendance.
Prices
Price per person:
€ 590,00
Price inhouse: € 1.950,00
Price inhouse: € 1.950,00
