Is ISO 14971 harmonized? 1.17K viewsOctober 10, 2022Medical Device 0 Sam Smith11.38K March 24, 2021 0 Comments Spread the loveSpread the love 1 Answer ActiveVotedNewestOldest 0 Blogolu28.38K Posted March 30, 2021 0 Comments Spread the loveRegulatory requirements for risk management Although it isn’t currently harmonized to the Regulations, EN ISO 14971:2019 represents the state-of-the-art for risk management. Spread the love You are viewing 1 out of 1 answers, click here to view all answers. Login