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Post-market surveillance

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Guest user Created:   May 10, 2021 Last commented:   May 11, 2021

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.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić May 11, 2021

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:

More information on the Post-market surveillance system you can find on the following links: How Post-market surveillance is covered in ISO 13485:2016&MDR Documentation toolkit, you can see on the following links:
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Susan Alexander May 11, 2021

This is a really helpful response to the question

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May 10, 2021

May 11, 2021