The IEC 62304 describes how to develop and document software for medical devices. This is an overview over our free templates which we’ve published for the IEC 62304 so far. In other words, if you use these templates, you have a pretty good chance of being compliant with the IEC 62304 :) Enjoy!

The best news is that we’ve published all our IEC 62304 templates for free! Check them out below.

Also note that we have many more templates besides the ones for IEC 62304 - head over to our templates page for more templates.

And finally, do you want to draft your own QMS with just one click? With Formwork, our eQMS software, combined with our free templates and a little bit of ChatGPT magic, you can draft your QMS in minutes. Check out the video below to see how it works.

All IEC 62304 Templates

Template: SOP Machine Learning Model Development (AI)

Template: Instructions On Data Annotation (Machine Learning / AI)

Template: Instructions On Data Acquisition (Machine Learning / AI)

Template: Document Roadmap for Technical Documentation

Template: Software Architecture Checklist

Template: Software Architecture Description

Template: SOP Deployment

Template: List of Medical Devices

Template: Machine Learning Algorithm Validation Report

Template: User Needs List

Template: List of Known Anomalies

Template: Change Evaluation List

Template: Bug Fixes Documentation List

Template: Checklist: Software Release

Template: Checklist: Software Requirements Review

Template: SOP Integrated Software Development

Template: SOP Change Management

Template: SOP Software Problem Resolution

Template: IEC 62304:2006 Mapping of Requirements to Documents

Template: SOUP List (Software of Unknown Provenance)

Template: Software System Test Plan

Template: Software Requirements List

Template: Software Development and Maintenance Plan

Template: Checklist: User Needs Review

Questions Other Companies Ask Us About IEC 62304

Do We Have to Re-Do All Software System Tests After a Minor Change?

Can We Use GitHub and Other SaaS For Our Software as a Medical Device?

Should You Automate Your Software Architecture Documentation?

Do Auditors Read Your Code?

How to document SOUP for IEC 62304 compliance?

All IEC 62304 Articles

Doing a Software Release in Compliance With IEC 62304

Software System Testing Based on the IEC 62304

Medical Device Software Architecture Documentation (IEC 62304)

Software Verification For Medical Device Software (IEC 62304)

Writing Software Requirements Based on the IEC 62304

Writing a Software Development and Maintenance Plan for IEC 62304 Compliance

IEC 62304 Walkthrough