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This Software SOUP/OTS documentation template provides guidelines for documenting the use of SOUP (or OTS) software items. The basis for the template has been the FDA guidance “Off-The-Shelf Software Use in Medical Devices” because an FDA submission typically expects dedicated documentation for OTS software.
The use of SOUPs in medical device software development is widespread and is often considered a valuable asset in software design. This template is useful to document essential properties of SOUP items and their relations to the overall software system.
You have two options when using this template:
In this template, instructions and/or explanations are included using blue italic texts such as these. Instructions and explanations should be removed before reviewing the document. All texts that are not blue are example texts that can and should be edited by you.
Texts that most certainly should be replaced or updated are identified by the { and } characters.
They should be removed, and the example text should be customised to work with the current project.
If you have questions about the template’s content, you may ask questions in the support forum. The support forum is accessible on this link when logged into your Medical Device HQ account.
If you should want to know more about medical device software development and IEC 62304, the topic is covered in our public training courses: Introduction to Software for Medical Devices and IEC 62304, Introduction to SaMD, IEC 62304 and IEC 82304-1, and Software for Medical Devices and IEC 62304 blended course. Our blended courses combine a self-paced online course first, followed by a live virtual classroom session facilitated by an industry expert.
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