ISO 13485 & EU MDR / 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
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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:
Additionally, we have prepared the following procedures and associated templates, required by MDR:
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