Standards For Manufacture And Quality Management Of Medical Device

https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices

ISO - ISO 13485 — Medical devices

https://www.iso.org/iso-13485-medical-devices.html

Medical devices. Safety and quality are non-negotiable in the medical devices industry, that’s why we developed ISO 13485. Regulatory requirements are increasingly …

ISO - ISO 13485:2016 - Medical devices — …

https://www.iso.org/standard/59752.html

It is the responsibility of the organization to ensure that claims of conformity to ISO 13485:2016 reflect any …

Quality and Compliance (Medical Devices) | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/quality-and-compliance-medical-devices

The FDA has established Quality System Regulations (QSR) addressing device design and validation as well as good manufacturing practices. The FDA’s regulations also address …