MDD Class I software technical documentation sample

I

Ivan S

#1
Hello,

I have a question regarding technical documentation for MDD Class I software, specifically Device description. How detailed must be the individual parts of the device description such as general description, intended use ect. Are there any specific content requirements for each of these parts arising from certifing a software?

If anyone could provide me with a sample of tech documentation (or device description only) for sw, it would be a great help.
:thanx:

P.S.: Attaching STED guidelines which im following.
 

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yodon

Staff member
Super Moderator
#2
Hard question to answer and providing an example would be difficult (for me) due to confidentiality agreements. Have you looked at ISO 62304? That provides good guidance on documentation for software, based on safety class. (It's a harmonized standard in the EU and recognized consensus standard in the US so if you market in either of those, you'll want to be compliant, anyway).
 

moounir

Involved In Discussions
#3
One advice that I can provide is for you to confirm with your Device Description that this is a Medical Device. By confirming that your product is a "Software that prognosis a disease and provide a treatment by analyzing the patient data" you are then matching the definition.
Then if you are more specific on which disease and which treatment we are talking about then its even better.

The objective of this section is to confirm that the product is a Medical Device and to provide information to the person who will read the technical file in terms of the context. If you want some support to overcome this "Software as a Medical Device" you can read that article.

I hope this helps.
 
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