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.

Technical Documentation

Medical Device Translation: 3 Steps For Medical Device Software

MDR Examples: Classification Examples for EU MDR Devices

IEC 62304 Walkthrough

Writing a Software Development and Maintenance Plan for IEC 62304 Compliance

Writing Technical Documentation

Writing Software Requirements Based on the IEC 62304

Software Verification For Medical Device Software (IEC 62304)

Medical Device Software Architecture Documentation (IEC 62304)

Software System Testing Based on the IEC 62304

Doing a Software Release in Compliance With IEC 62304

ISO 14971 Walkthrough

FMEA, Part 1: Risk Acceptance Matrix (ISO 14971 Risk Analysis)

How to Get a UDI (Unique Device Identifier) For MDR Compliance

How To Do a Summative Usability Testing For IEC 62366 Compliance

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

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

How To Do Formative Usability Testing For Medical Devices