# Checklist: Software Release

| Classes | IEC 62304:2006 Section | Document Section |
| ------- | ---------------------- | ---------------- |
| A, B, C | 5.8.1 | (All) |
| A, B, C | 5.8.2 | (All) |
| A, B, C | 5.8.3 | (All) |
| A, B, C | 5.8.4 | (All) |
| B, C | 5.8.5 | (All) |
| B, C | 5.8.6 | (All) |
| A, B, C | 5.8.7 | (All) |

## Summary

This checklist is used to verify that documentation and activities are complete before releasing a new version of the product.

> 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.

> 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.

## Checklist

The following documents are up to date:

> The table below shows examples only. Add - or reference - a list of all your required TechDoc records.

| Item | Yes | No | Comment |
| ---- | --- | --- | ------- |
| Device Description |  |  |  |
| Clinical Evaluation |  |  |  |
| Declaration of Conformity |  |  |  |
| (...) |  |  |  |

The following activities have been performed:

| Item | Yes | No | Comment |
| ---- | --- | --- | ------- |
| All relevant functionalities of the software have been specified; the Software Requirement List is complete and has been reviewed. |  |  |  |
| All relevant risks (including risks of known anomalies) have been evaluated; the Risk Management Report is complete. |  |  |  |
| Verification (as software system testing) has been completed. |  |  |  |
| 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. |  |  |  |
| A version number as defined in the Software Development Plan has been assigned and added as a tag to git. |  |  |  |
| Software is registered with a Notified Body. |  |  |  |
| If release includes substantial change: Notified Body has been informed. |  |  |  |
| Label is applied correctly including CE marking. |  |  |  |

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