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Clinical Evaluation Template #12
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Hello! As per our discussion, clinical evaluation is required by the EU even if the device is of class I (least concern). It could go under the topic of product validation, as defined in IEC 82304-1 for software-only products and recognized by FDA. I could write two templates called:
as we have written such documents before. Discussion topics:
Reference: About product validation in general:
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@ahnurmi thank you for writing out all of these details. I am only familiar with 62304, but it would be great if we could support 82304-1 as well. I have wondered about the best way to support options like this. It could be a prompt that occurs when you run
Alternatively, we could keep the options in
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