Articles

Updated December 2, 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

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

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Dr. Oliver Eidel

I'm a medical doctor, software engineer and regulatory dude. I've helped 50+ companies with their medical device compliance. I mainly work as a regulatory consultant, but my goal is to make consulting unnecessary by publishing all of our articles and templates for free :)

If you're still lost and have further questions, just send me an email. Read more about me here.

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