Impact assessment EN ISO 14971 -- EN ISO 14971: 2019 - Risk Management for Medical Devices

Here are a Summary of the Signiant changes that will be illustrated during the event:

• 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.