Usability & Human Factors Knowledge Platform

Expert knowledge for user-centered medical technology development: standards-compliant and from practice

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Knowledge platform topics

Gloved hands holding sterile medical device packaging whose label is partly hard to read because of glare
October 2026

Testing Label Legibility Under Realistic Lighting Conditions

How formative usability tests show whether labeling is reliably found and understood in the context of..

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Observation room in the USE-Ing. usability lab with monitors for live observation of studies
October 2026

Planning Data Protection in Usability Studies from the Start

Why study type, setting and data flow must be clarified before the first consent form is..

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Packaging usability engineering
July 2026

Usability Evaluation of Medical Device Packaging

Why the first interaction with a sterile medical device happens at its packaging, and how usability..

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HCP recruiting for usability tests: figures representing healthcare roles
June 2026

HCP Recruiting for Usability Tests: Why the Wrong Participants Become a Problem

Why HCP recruiting for usability tests becomes the decisive bottleneck and how medical device developers can..

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Usability engineering for AI-enabled medical devices
May 2026

Usability Engineering for AI-enabled Medical Devices

How to master human-AI interaction in line with IEC 62366 and the EU AI Act through..

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Hazard-related use scenarios
April 2026

How do you create hazard-related use scenarios and a use-related risk analysis?

How to derive hazard-related use scenarios from task analysis and use errors, and how they feed..

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Formative usability evaluation
February 2026

How do you conduct formative usability evaluations in accordance with IEC 62366-1?

How to plan, run and document formative usability evaluations under IEC 62366-1: methods, design and safety..

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Human factors validation for FDA submissions
January 2026

How do you conduct human factors validation tests in compliance with FDA requirements?

How to plan FDA human factors validation testing: critical tasks, simulated-use conditions, at least 15 participants..

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Header_NMPA
September 2025

Usability requirements for medical devices on the Chinese market in accordance with NMPA

NMPA Usability Requirements for Medical Devices on the Chinese Market What Manufacturers Need to Know September..

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