Risk management for medical devices EN ISO 14971-2019

Training on how to implement the specifications of risk management for medical devices

Training days: 2 Days

Target: Know how the regulatory and normative requirements for the risk management of medical devices can be implemented in a system. The participants are able to set up and operate a risk management system for medical devices that fulfils the regulatory and normative requirements. Risk analysis and FMEA can be linked together. The analysis of risks with the tools of risk management can be moderated.

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

Target groups: - Manufacturers of medical devices and their suppliers - Quality management representatives (QMB) - Safety representative for medical devices - Responsible person according to MDR Art. 15 (PRRC) - Product and process developers - Persons responsible for the implementation of risk management requirements - Persons responsible for the analysis, evaluation and mitigation of risks

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