Risk management for medical devices EN ISO 14971-2019

Training days: 2 Days

Description: - Why risk management - Regulatory and normative requirements - Risk management terms - Establish risk policy - Setting risk acceptance limits - Creating risk management plans - Use risk management tools correctly - Establish criteria for assessing risks and residual risks - Methods for risk control - Methods for evaluating residual risks and the overall residual risk - Methodology for monitoring the downstream phase of production - Prepare risk management reports - 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: 4 to 12 Persons

Services: All participants receive: Manual (plus costs for in-house training) and certificate of attendance.

Price per person: € 1.180,00
Price inhouse: € 3.900,00