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Updated October 12, 2022

Technical Documentation

Dr. Oliver Eidel

Technical Documentation is about describing which features your software has, which risks those features include, and how you do your testing. You also have to do usability (user) testing.

All Technical Documentation Articles

MDR Classification: Examples for EU MDR Devices
IFA UDI Hack: Save Money By Using a Health Product Code (HPC)
How To Do a Summative Usability Evaluation For IEC 62366 Compliance
The IEC 62366 (Usability) Summary: All You Need To Know (It's Not Much)
Clinical Evaluation: How to Write a Regulatory Compliant Literature Review
Medical Device Translations: 3 Steps For Translating Software as a Medical Device
Performance Evaluation
Clinical Evaluation
IEC 62366
ISO 14971
IEC 62304
How to Get a UDI (Unique Device Identifier) For MDR Compliance
FMEA, Part 1: Risk Acceptance Matrix (ISO 14971 Risk Analysis)
ISO 14971 Walkthrough
Clinical Evaluation Report (CER) For Medical Devices: 3 Easy Steps
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 Technical Documentation
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.