Articles About Technical Documentation

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.

Articles About Technical Documentation

Clinical Evaluation Report: Literature Search – SaMD

MDR Classification: Examples for EU MDR Devices

IFA UDI Hack: Save Money By Using a Health Product Code (HPC)

The IEC 62366 (Usability) Summary: All You Need To Know (It’s Not Much)

How To Do a Summative Usability Evaluation For IEC 62366 Compliance

Clinical Evaluation: How to Write a Regulatory Compliant Literature Review

Medical Device Translations: 3 Steps For Translating Software as a Medical Device

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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