Impact assessment EN ISO 14971 -- EN ISO 14971: 2019 - Risk Management for Medical Devices
Wed 15 Sept
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Time & Location
15 Sept 2021, 10:00 – 12:30 CEST
Link to be provided upon subscription
About the Event
Summary of the Significant changes:
Fundamental understanding and process for risk management has not changed.
Introduction of new definitions (benefit, reasonably foreseeable misuse & state of the art).
Increased attention to benefit-risk analysis, aligning the concept with terminology used in the MDR.
Additional emphasis on the scope of the ISO 14971-risk management process, i.e. all risks associated with a medical device, ranging from risks related to electricity, usability, data security etc.
The risk management plan has to define the methods and criteria to evaluate acceptability of the overall residual risk.