Closing The Loop On Risk Management With ISO 149712019
Closing The Loop On Risk Management With ISO 14971:2019 This is the second 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 major change in the process: product...
Source: meddeviceonline.com