Usability Engineering & Human Factors
Usability Engineering & Human Factors
Enhancing User Safety Through Human-Centered Product Development
Even technically advanced medical devices may present risks if their operation is unclear, prone to use errors, or insufficiently adapted to the intended users.
Avary Consulting supports manufacturers in systematically integrating usability engineering and human factors into product development.
Our consulting services consider IEC 62366-1, ISO 14971, applicable MDR and IVDR requirements, and the FDA guidance Applying Human Factors and Usability Engineering to Medical Devices.
Our services include:
- Development of usability engineering plans
- Analysis of user groups, use scenarios, and use environments
- Identification of safety-related use errors
- Support for use-related risk analysis
- Planning of formative usability evaluations
- Coordination of summative usability validation activities
- Support for usability engineering files and regulatory documentation
Our Recommendation for Manufacturers: Integrate human factors considerations into early design decisions. Identifying critical use scenarios at an early stage can reduce design changes and subsequent regulatory questions.