Post-market surveillance
I wonder if you can help me with one question, please? I have read that ISO 13485 2016 places emphasis on post-market surveillance, and this terms appears in the glossary. Yet I cannot find this term in the text of the standard, although I suppose the meaning is in Section 8. Is there anywhere in the standard that actually asks for post market surveillance please?
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
There is no in ISO 13485:2016 direct requirement for Post-market surveillance. In MDR there is a requirement that a post-market surveillance system must be in place as part of the quality management system (Article 10, point 9).
For more information, see:
- EU MDR Article 10 – General obligations of manufacturers https://advisera.com/13485academy/mdr/general-obligations-of-manufacturers/
More information on the Post-market surveillance system you can find on the following links:
- What are the post-market surveillance requirements in the MDR? https://advisera.com/13485academy/blog/2021/04/29/what-are-the-post-market-surveillance-requirements-in-the-mdr/
How Post-market surveillance is covered in ISO 13485:2016&MDR Documentation toolkit, you can see on the following links:
- Procedure for Post-Market Surveillance System https://advisera.com/13485academy/documentation/procedure-for-post-market-surveilance/
- Post-Market Surveillance Plan https://advisera.com/13485academy/documentation/post-market-surveilance-plan/
- Post-Market Surveillance Report https://advisera.com/13485academy/documentation/post-market-surveilance-report/
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May 11, 2021