ISO 14971:2019 â Clarifying Benefit, Risk, & Benefit-Risk
This is the third in a series of articles on the changes in the medical device risk management standard ISO 14971 that were released in December of 2019 and supported by guidance in the ISO TR 24971:2020 technical report or guidance on the medical device risk management standard. The standard and the technical report were reorganized and clarifications of the concepts of medical device risk management were included in the two documents. Few changes in the process resulted, but this article covers the change in the process for benefit-risk covered in Clause 8 of the standard.
The Evolution Of The Terms “Benefit” And “Risk” In ISO 14971