GSO ISO/TR 24971:2024
ISO/TR 24971:2020
Gulf Standard
Current Edition
·
Approved on
14 October 2024
Medical devices — Guidance on the application of ISO 14971
GSO ISO/TR 24971:2024 Files
English
0 Pages
Current Edition
Reference Language
GSO ISO/TR 24971:2024 Scope
This document provides guidance on the development, implementation and maintenance of a risk management system for medical devices according to ISO 14971:2019.
The risk management process can be part of a quality management system, for example one that is based on ISO 13485:2016[24], but this is not required by ISO 14971:2019. Some requirements in ISO 13485:2016 (Clause 7 on product realization and 8.2.1 on feedback during monitoring and measurement) are related to risk management and can be fulfilled by applying ISO 14971:2019. See also the ISO Handbook: ISO 13485:2016 — Medical devices — A practical guide[25].
Best Sellers From Health Sector
GSO 2017:2023
Gulf Standard
Personal Care and Baby Wet Wipes
YSMO GSO 2017:2023
GSO 2017:2023
Yemeni Standard
Personal Care and Baby Wet Wipes
GSO 2241:2023
Gulf Standard
Cosmetic Products - Body Cleaners
GSO 1223:2023
Gulf Standard
Cosmetic Products-Deodorants
Recently Published from Health Sector
GSO ISO 1797:2025
ISO 1797:2017
Gulf Standard
Dentistry — Shanks for rotary and oscillating instruments
GSO ISO 16571:2025
ISO 16571:2024
Gulf Standard
Systems for evacuation of plume generated by medical devices
GSO ISO 7787-1:2025
ISO 7787-1:2016
Gulf Standard
Dentistry — Laboratory cutters — Part 1: Steel laboratory cutters
GSO ISO 18562-3:2025
ISO 18562-3:2024
Gulf Standard
Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic substances