ISO 14971:2020 Risk Management for Medical Devices
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Course description
A comprehensive course on applying ISO 14971:2019/AMD1:2020 and ISO/TR 24971:2020 to the medical device risk management process, integrating the product life cycle with the Quality Management System and meeting ANVISA, FDA and MDR 745/2017 requirements simultaneously.
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Course objective
Train professionals to plan, implement and maintain a risk management process under ISO 14971, from initial analysis to post-market surveillance, producing the Risk Management File required by all major regulatory authorities.
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Course programme
- 01
Fundamentals of medical device risk management
- 02
The ISO 14971:2020 process and its relationship with ISO/TR 24971:2020
- 03
Risk analysis, evaluation, control and residual risk
- 04
Benefit-risk and acceptability
- 05
Integration with design, production and post-market activities
- 06
Risk Management Plan and Risk Management Report
- 07
ANVISA, FDA and MDR regulatory expectations
04
Who can attend?
- Product engineers, R&D, Quality and Regulatory Affairs professionals, risk managers and auditors working on medical device development and maintenance.