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Updated January 20, 2021

Template: Checklist: Software Release

Dr. Oliver Eidel
IEC 62304

This is a free template, provided by OpenRegulatory.

A preview of the template is shown below. You can download it as Word (.docx), PDF or markdown file.

The template license applies (don't remove the copyright at the bottom).

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Beginning of template

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 release a new version of the product.

As with all regulatory documents, it’s more about then 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 tepmlate is pretty much the bare minimum to be 62304-compliant.

Checklist

The following documents are up to date:

Item Yes No Comment
Device Description      
Clinical Evaluation      
Known anomalies      
Risk Analysis      
Usage Scenarios      
Declaration of Conformity      

The following activities have been performed:

Item Yes No Comment
Risks of known anomalies have been evaluated.      
Usability Evaluation has been (re-)done and documented, if necessary.      
Software Development Documentation is complete (Requirements, Architecture).      
Software Testing has been completed.      
A version number as defined in the Software Development Plan has been assigned and added as a tag to git.      
Software is registered with Notified Body.      
If release includes substantial change: Notified Body has been informed.      
Label is applied correctly including CE marking.      

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Please don’t remove this notice even if you’ve modified contents of this template.

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