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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 in the basics of risk management for medical devices in accordance with the requirements of the MDR and EN ISO 14971:2019
Training days: 1 Day
Target: Understanding of the principles and overview of the tools of risk management for medical devices.
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
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: 5 to 12 Persons
Services: All participants receive: Handout (plus costs for in-house) and certificate of attendance.
Price per person: € 590,00
Price inhouse: € 1.950,00
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