Updated May 18, 2022

Template: Checklist: Software Release

Dr. Oliver Eidel

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Related Documents

The following templates are Documents or SOPs related to this template. That means that they mention this template somewhere and (most likely) contain instructions on how and when to fill it out.

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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 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:
Stakeholder requirements can be traced to software requirements.
Software requirements can be traced to system tests.
Software requirements can be traced to software code implementation / software code reviews.
Software requirements can be traced to risks and risk control measures.
Stakeholder requirements can be traced to usability tests.
Hazard-related use scenarios can be traced to usability tests.
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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