53 lines
2.8 KiB
Markdown
53 lines
2.8 KiB
Markdown
# Checklist: Software Release
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| Classes | IEC 62304:2006 Section | Document Section |
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| ------- | ---------------------- | ---------------- |
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| A, B, C | 5.8.1 | (All) |
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| A, B, C | 5.8.2 | (All) |
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| A, B, C | 5.8.3 | (All) |
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| A, B, C | 5.8.4 | (All) |
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| B, C | 5.8.5 | (All) |
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| B, C | 5.8.6 | (All) |
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| A, B, C | 5.8.7 | (All) |
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## Summary
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This checklist is used to verify that documentation and activities are complete before releasing a new version of the product.
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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 this checklist out every time in Word / GDocs / etc., but could embed it in your Jira / GitHub workflow. The main point is that, at minimum, the items below should be checked (and documented) before you release a new version of your software.
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> Feel free to add further rows in the checklist if they make sense for your company. This template is pretty much the bare minimum to be 62304-compliant.
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## Checklist
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The following documents are up to date:
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> The table below shows examples only. Add - or reference - a list of all your required TechDoc records.
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| Item | Yes | No | Comment |
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| ---- | --- | --- | ------- |
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| Device Description | | | |
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| Clinical Evaluation | | | |
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| Declaration of Conformity | | | |
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| (...) | | | |
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The following activities have been performed:
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| Item | Yes | No | Comment |
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| ---- | --- | --- | ------- |
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| All relevant functionalities of the software have been specified; the Software Requirement List is complete and has been reviewed. | | | |
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| All relevant risks (including risks of known anomalies) have been evaluated; the Risk Management Report is complete. | | | |
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| Verification (as software system testing) has been completed. | | | |
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| Design control traceability is ensured:<br>Stakeholder requirements can be traced to software requirements.<br>Software requirements can be traced to system tests.<br>Software requirements can be traced to software code implementation / software code reviews.<br>Software requirements can be traced to risks and risk control measures.<br>Stakeholder requirements can be traced to usability tests.<br>Hazard-related use scenarios can be traced to usability tests.<br>Hazard-related use scenarios can be traced to risks and risk control measures. | | | |
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| A version number as defined in the Software Development Plan has been assigned and added as a tag to git. | | | |
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| Software is registered with a Notified Body. | | | |
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| If release includes substantial change: Notified Body has been informed. | | | |
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| Label is applied correctly including CE marking. | | | |
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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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