Complying with ISO 14971
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Yes, because requirement 7.1 Planning of product realization points to the ISO 14971 for further information regarding the risk management for the medical devices. Furthermore, all medical device manufacturers must be in compliance with the harmonized standards which are published in the Official Journal of the European Commission (Annex 8 of the MDR 2017/745). On that list, ISO 14971:2019 is the only standard that covers risk management.
For more information, see:
EU MDR Article 8 – Use of harmonised standards - https://advisera.com/13485academy/mdr/use-of-harmonised-standards/
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Jun 04, 2021