51 lines
2.2 KiB
Markdown
51 lines
2.2 KiB
Markdown
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# Checklist: Software Requirements Review
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| Classes | IEC 62304:2006 Section | Document Section |
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|---------|------------------------|------------------|
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| A, B, C | 5.2.6 | (All) |
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| ISO 13485:2016 Section | Document Section |
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|------------------------|------------------|
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| 7.3.3 | (All) |
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| 7.3.5 | (All) |
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## 1. Summary
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This checklist is used to review (verify) software requirements prior to implementation.
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> As with all regulatory documents, it's more about the content than about the tool. You don't have to fill
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> this checklist out every time in Word / GDocs / etc., but could embed it in your Jira / GitHub workflow. The
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> main point is that, at minimum, the items below should be filled out before you start implementing software
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> requirements.
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> Feel free to add further rows in the checklist if they make sense for your company. This template is pretty
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> much the bare minimum to be 62304-compliant.
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## 2. Checklist
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| Software Requirements... | Yes | No | Comment |
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|-------------------------------------------------------------------------------|-----|----|---------|
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| are traceable to design input or risk control measures. | | | |
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| are complete. | | | |
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| are understandable, uniquely identifiable and do not contradict each other. | | | |
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| include user interface requirements (mockups, wireframes, etc.), if relevant. | | | |
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| include IT security requirements, if relevant. | | | |
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| are testable and include acceptance criteria. | | | |
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# 3. Comments
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\<Insert comments if applicable\>
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# 4. Result
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[ ] Software Requirements passed\
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[ ] Software Requirements not passed\
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[ ] Software Requirements passed with the following obligations: \<Insert if applicable\>\
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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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