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Is the Technical File still a requirement?

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Guest user Created:   Mar 09, 2021 Last commented:   Mar 11, 2021

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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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 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:

In Our ISO 13485:2016&MDR Integrated toolkit we have prepared the following procedures and templates:

Additionally, we have prepared the following procedures and associated templates, required by MDR:

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Mar 11, 2021

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