Medical Device Iso

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 stringent throughout every step of a product’s life cycle, including service and delivery. …

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

Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of …

ISO - ISO 20417:2021 - Medical devices — Information …

https://www.iso.org/standard/67943.html

NOTE 1 There is guidance or rationale for this Clause contained in Clause A.2. This document specifies the requirements for information supplied by the …

ISO - New ISO standards for medical devices

https://www.iso.org/news/ref2534.html

ISO 20417, Medical devices – Information to be supplied by the manufacturer, simplifies the process of meeting product information regulations …