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ISO - ISO 13485 — Medical devices
- https://www.iso.org/iso-13485-medical-devices.html
- ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing …
ISO - ISO 13485:2016 - Medical devices — Quality …
- https://www.iso.org/standard/59752.html
- Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. …
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 …
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 manufacturer …
Ultimate List of ISO Standards for Medical Devices
- https://www.greenlight.guru/blog/iso-standards
- Oct 5, 2022
ISO - ISO 14155:2020 - Clinical investigation of medical …
- https://www.iso.org/standard/71690.html
- Preview. This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to …
Medical devices - ISO
- http://policy.iso.org/medical-devices.html
- For example: The IEC 60601 series is widely recognized as the fundamental safety standards for medical electrical equipment. IEC 62366 has established a broadly …
ISO 13485 - Wikipedia
- https://en.wikipedia.org/wiki/ISO_13485
- ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for …
ISO - IEC 62366-1:2015 - Medical devices — Part 1: …
- https://www.iso.org/standard/63179.html
- Medical devices — Part 1: Application of usability engineering to medical devices This standard was last reviewed and confirmed in 2021. Therefore this version remains …
ISO - ISO 15223-1:2016 - Medical devices — Symbols to …
- https://www.iso.org/standard/69081.html
- ISO 15223-1:2016 identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices. It also lists symbols …
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