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Updated November 22, 2022

IEC 62304 Templates

Dr. Oliver Eidel

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

On a slighty different note: You want to get your medical software certified under MDR but don't know where to start? No worries! That's why we built the Wizard. It's a self-guided video course which helps you create your documentation yourself. No prior knowledge required. You should check it out.

Or, if you're looking for the most awesome (in our opinion) eQMS software to manage your documentation, look no further. We've built Formwork, and it even has a free version!

If you're looking for human help, did you know that we also provide some limited consulting? It's limited because we are not many people. We guide startups from start to finish in their medical device compliance.

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Dr. Oliver Eidel

I'm a medical doctor, software engineer and regulatory dude. I'm also the founder of OpenRegulatory.

Through OpenRegulatory, I've helped 100+ companies with their medical device compliance. While it's also my job that we stay profitable, I try to dedicate a lot of my time towards writing free content like our articles and templates. Maybe that will make consulting unnecessary some day? :)

If you're still lost and have further questions, reach out any time!

No QMS on this planet will save you from creating crappy software.