Template: Checklist: Software Release

Template Download

This is a free template, provided by OpenRegulatory.

If you are a user of Formwork, our eQMS software, choose “QMS” on the top menu and “OpenRegulatory Templates” on the left menu, and then open the relevant folder to find this template ready to load into Formwork.

If, for some mysterious reason, you’re using a different QMS Software, you can also simply download this template – specifically, as Word (.docx), PDF, Google Docs or Markdown file. Scroll down for a preview!

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

Tired of copy-pasting? If you want to save time and edit these templates directly, you can use Formwork, our eQMS software. And if you’re looking for step-by-step instructions for filling them out, check out our Wizard 🙂

Don't Miss Updates to This Template
Subscribe to our newsletter and we'll keep you posted on which templates we've changed.

Questions? Still Lost in Regulation?

Good news! Our goal is to provide lots of stuff for free, but we also offer consulting if you need a more hands-on approach. We get stuff done really fast. Have a look!

Template preview
ClassesIEC 62304:2006 SectionDocument Section
A, B, C5.8.1(All)
A, B, C5.8.2(All)
A, B, C5.8.3(All)
A, B, C5.8.4(All)
B, C5.8.5(All)
B, C5.8.6(All)
A, B, C5.8.7(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.

ItemYesNoComment
Device Description
Clinical Evaluation
Declaration of Conformity
(…)

The following activities have been performed:

ItemYesNoComment
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.

Template Copyright openregulatory.com. See template license.

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

Template preview

Comments

Leave the first comment