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Risk management for medical devices EN ISO 14971-2019

Application of risk management for medical devices (EN ISO 14971:2019) (STTT-B6D-P2)

Short description
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
01. 08. - 02. 08. 2024 Register
07. 11. - 08. 11. 2024 Register