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.

Doing The Literature Review For Clinical Evaluation Reports for Software as a Medical Device

Clinical Evaluation
May 14, 2024

MDR Classification: Examples for EU MDR Devices

Technical Documentation
Medical Device Classification
October 18, 2023

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

Technical Documentation
UDI
August 21, 2023

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

Technical Documentation
IEC 62366
July 7, 2023

How To Do a Summative Usability Evaluation For IEC 62366 Compliance

Technical Documentation
IEC 62366
July 7, 2023

Clinical Evaluation: How to Write a Regulatory Compliant Literature Review

Clinical Evaluation
May 24, 2023

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

Technical Documentation
May 24, 2023

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

Technical Documentation
UDI
May 24, 2023

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

Technical Documentation
ISO 14971
May 24, 2023

ISO 14971 Walkthrough

Technical Documentation
ISO 14971
May 24, 2023

Clinical Evaluation Report (CER) For Medical Devices: 3 Easy Steps

Clinical Evaluation
May 24, 2023

Doing a Software Release in Compliance With IEC 62304

Technical Documentation
IEC 62304
May 24, 2023

Software System Testing Based on the IEC 62304

Technical Documentation
IEC 62304
May 24, 2023

Medical Device Software Architecture Documentation (IEC 62304)

Technical Documentation
IEC 62304
May 24, 2023

Software Verification For Medical Device Software (IEC 62304)

Technical Documentation
IEC 62304
May 24, 2023

Writing Software Requirements Based on the IEC 62304

Technical Documentation
IEC 62304
May 24, 2023

Writing Technical Documentation

Technical Documentation
May 24, 2023

Writing a Software Development and Maintenance Plan for IEC 62304 Compliance

Technical Documentation
IEC 62304
May 24, 2023

IEC 62304 Walkthrough

Technical Documentation
IEC 62304
May 24, 2023