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1
ISO 13485:2016 - Medical devices — Quality management systems
https://www.iso.org/standard/59752.html
5
Quality Management System Regulation: Final Rule - FDA
https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp/quality-management-system-regulation-final-rule-amending-quality-system-regulation-frequently-asked
6
ISO 13485:2016(en), Medical devices — Quality management systems
https://www.iso.org/obp/ui/%23iso:std:iso:13485:ed-3:v1:en
7
ISO 13485 for Medical Devices QMS [Complete Guide] - Greenlight Guru
https://www.greenlight.guru/blog/iso-13485-qms-medical-device
8
ISO 13485 - Quality Management System - BSI
https://www.bsigroup.com/en-US/products-and-services/standards/iso-13485-quality-management-system/
9
What is ISO 13485? Detailed Explanation of the Standard
https://advisera.com/13485academy/what-is-iso-13485/
10
ISO 13485 Certification - Medical Devices Management - NQA
https://www.nqa.com/en-us/certification/standards/iso-13485
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