57 lines
3.5 KiB
Markdown
57 lines
3.5 KiB
Markdown
# 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
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> to just put all product-related documents into a folder in your QMS so that the association is
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> clear. Alternatively, you could mention the related product and version here, but then you'd have to update
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> the version here any time you do a new release. Painful!
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> This is a list of your software requirements. If you have multiple software systems (you probably have a
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> backend and a frontend), you can use the "Software System" column. The categories are the 62304 categories
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> from section 5.2.2. *Risk Control Measure?* is just a yes/no field. And the related risk IDs refer to the
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> risk IDs from your risk table.
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> Of course, you could also use your own tool like Jira or GitHub issues. Just ensure that the content (i.e.,
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> the columns shown here) is roughly the same.
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## Mapping of Standard Requirements to Document Sections
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| Classes | IEC 62304:2006 Section | Document Section |
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|---------|------------------------|------------------|
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| A, B, C | 5.2.1, 5.2.2, 5.2.3 | 1 |
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| ISO 13485:2016 Section | Document Section |
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|------------------------|------------------|
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| 7.2.1 | (All) |
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| 7.3.3 | (All) |
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| IEC 62366-1:2015 Section | Title | Document Section |
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|--------------------------|------------------------------------------------------------------------------------|------------------|
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| 5.2 | Identify User Interface characteristics related to Safety and potential Use Errors | 1 |
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| 5.6 | Establish User Interface Specification | 1 |
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## 1. Software Requirements
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> While the 62034 "only" requires you to document Software Requirements, the 13485 also wants you to document
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> higher-level customer requirements. You could solve that by having a two-stage hierarchy of requirements: On
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> the first level, you'd have user stories (= the 13485 customer requirements), and beneath that, for each
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> user story, you'd have more technical specifications (= 62304 software requirements).
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> There's no great way to display this in a table, so for now, this table only solves the problem of defining
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> software requirements. Feel free to create a second table for user stories, or just cram them into this one
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> (good luck).
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| ID | Software System | Category | Description | Risk Control Measure? | Related Risk IDs |
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|----|-----------------|----------------|------------------------------------|-----------------------|------------------|
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| 1 | App | Functional | On first launch, show introduction | No | |
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| 2 | App | User Interface | Use user locale (language) | No | 1 (Risk ID) |
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| 3 | App | Functional | Average CPU usage < 2% | No | |
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| 4 | Backend | Security | Store passwords as hashes | Yes | |
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| 5 | Backend | Interface | Expose a REST API, handle JSON | No | |
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---
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Template Copyright [openregulatory.com](https://openregulatory.com). See [template
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license](https://openregulatory.com/template-license).
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Please don't remove this notice even if you've modified contents of this template.
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