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Mandatory documents for SaMD to develop QMS

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Guest user Created:   Sep 20, 2021 Last commented:   Sep 20, 2021

Mandatory documents for SaMD to develop QMS

I have a question for you, and want to ask for your opinion.

We are an  AI software team in a *** hospital. Our product is similar to ***. Our pneumothorax algorithm could automatically identifies findings suggestive of Pneumothorax based on chest X-ray scans and outputs an alert.

Because this product is a pure software, i.e. SaMD(Software and medical device), we do not manufacture physical medical equipment and don't have some activities. For example, there is no sterilization activity in our production processes.
 
I would like to know what documents are mandatory for a SaMD to develop a QMS?

Looking forward to hearing from you

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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 Sep 20, 2021

You do not need any sterilization documents of course. Considering the installation, if it is done by the user without any record for that, then you also do not need installation procedure and documents.

In your case, the service procedure will cover solving bugs and similar problems.

All other documentation is necessary for you, but you need to adjust it to your process. For example, you need Production and service procedure because here you will describe how you will program your software, who is involved in it, what kind of test you will do, how you will solve bugs, and so on.

You also need Purchasing procedure because you need to define specifications for programs for software programming and licenses. Also, if you use cloud service or have a server at your place, then you need to order some specific elements for the server.

You need a warehouse procedure if you use some computers, motherboards, hardware, and so on. If you use a server room then it is necessary for the server to be in an appropriate environment (temperature and humidity). In that case, you need to monitor the temperature and humidity in that room.  

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Sep 20, 2021

Sep 20, 2021