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Complying with ISO 14971

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Guest user Created:   Jun 02, 2021 Last commented:   Jun 04, 2021

Complying with ISO 14971

As part of the ISO 13485, do we also need to comply with ISO 14971?

 

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ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Jun 04, 2021

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 02, 2021

Jun 04, 2021