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Is the Technical File still a requirement?
Is the Technical File still a requirement? I do not see any mention to this in the updated ISO 13485
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Kristina Zvonar Brkić
Mar 11, 2021
In MDR there is a requirement for Technical documentation. It is covered in Annex 2 - Technical documentation and Annex 3 - Technical documentation on post-market surveillance.
For more details, please see:
- EU MDR Annex 2 – Technical documentation - https://advisera.com/13485academy/mdr/technical-documentation/
- EU MDR Annex 3 – Technical documentation on post-market surveillance - https://advisera.com/13485academy/mdr/technical-documentation-on-post-market-surveillance/
In Our ISO 13485:2016&MDR Integrated toolkit we have prepared the following procedures and templates:
- Technical file procedure https://advisera.com/13485academy/documentation/technical-file-procedure/
- Technical documentation checklist https://advisera.com/13485academy/documentation/technical-documentation-checklist/
Additionally, we have prepared the following procedures and associated templates, required by MDR:
- Procedure for clinical evaluation - https://advisera.com/13485academy/documentation/procedure-for-clinical-evaluation/
- Procedure for Post-Market Surveillance System - https://advisera.com/13485academy/documentation/procedure-for-post-market-surveilance/
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Mar 09, 2021
Mar 11, 2021
Mar 11, 2021