At a glance
- Short name
- ISO 13485
- Issuing / stewarding body
- ISO
- Jurisdiction
- International
- Also known as / related labels
- ISO 9001 · FDA 21 CFR 820 · EU MDR · MDSAP
What this entry covers
Evaluate compliance with ISO 13485:2016 Quality Management System requirements for medical device design, development, production, and servicing
MyRHC indexes this framework so practitioners, auditors, and automated agents can find the authoritative primary sources in one place. This page is a navigation aid — it is not legal advice and is not a substitute for the official text.
Official documentation
- Primary official source: https://www.iso.org/standard/59752.html
How to use this index entry
- Open the official link above (or the agency home if the deep link drifts).
- Confirm edition / revision date against your program scope.
- Map applicability by sector and jurisdiction listed in the metadata.
- Follow related frameworks only after checking their own official sources.
Disclaimers
- MyRHC does not host proprietary standards text (ISO, some industry bodies).
- Where standards are paywalled, we link to the publisher’s catalog page.
- Always verify current requirements with counsel and the issuing authority.
Index only — not legal advice.
MyRHC does not certify compliance. Confirm current requirements with the issuing authority and qualified counsel. Proprietary standards text remains with its publisher.