Template: Software Requirements List

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This document is related to your product. You somehow need to associate it with it. The easiest way would be to just put all product-related documents into a folder in your QMS so that the association is clear. Alternatively, you could mention the related product and version here, but then you’d have to update the version here any time you do a new release. Painful!

This is a list of your software requirements. If you have multiple software systems (you probably have a backend and a frontend), you can use the “Software System” column. The categories are the 62304 categories from section 5.2.2. Risk Control Measure? is just a yes/no field. And the related risk IDs refer to the risk IDs from your risk table.

Of course, you could also use your own tool like Jira or GitHub issues. Just ensure that the content (i.e., the columns shown here) is roughly the same.

Mapping of Standard Requirements to Document Sections

ClassesIEC 62304:2006 SectionDocument Section
A, B, C5.2.1, 5.2.2, 5.2.31
ISO 13485:2016 SectionDocument Section
IEC 62366-1:2015 SectionTitleDocument Section
5.2Identify User Interface characteristics related to Safety and potential Use Errors1
5.6Establish User Interface Specification1

1. Software Requirements

While the 62034 “only” requires you to document Software Requirements, the 13485 also wants you to document higher-level customer requirements. You could solve that by having a two-stage hierarchy of requirements: On the first level, you’d have user stories (= the 13485 customer requirements), and beneath that, for each user story, you’d have more technical specifications (= 62304 software requirements).

There’s no great way to display this in a table, so for now, this table only solves the problem of defining software requirements. Feel free to create a second table for user stories, or just cram them into this one (good luck).

IDSoftware SystemCategoryDescriptionRisk Control Measure?Related Risk IDs
1AppFunctionalOn first launch, show introductionNo
2AppUser InterfaceUse user locale (language)No1 (Risk ID)
3AppFunctionalAverage CPU usage < 2%No
4BackendSecurityStore passwords as hashesYes
5BackendInterfaceExpose a REST API, handle JSONNo

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