ANSI/AAMI/IEC 62366

Application of Human Factors for Medical Devices

Five Vital Elements for Design Success

Optimal usability engineering emphasizes a user-centered approach throughout the medical product design and development process.

This has been central to Metaphase’s best practices since we opened our doors in 1991. The user-centered approach is strongly emphasized in human factors engineering guidance documents ANSI/AAMI HE75 Human Factors Principles for Design of Medical Devices and IEC 62366 Application of Usability Engineering to Medical Devices. Specifically, HE75 targets a broad range of recommended usability engineering, user-centered, best-practices for human factors engineering while 62366 focuses on use safety. Following 62366 guidance ensures verification/formative and validation/summative studies align with both the FDA’s usability engineering requirements as well as the requirements of the European Union Medical Device Regulation (MDR) entities.

Competitive Product Benchmarking

• Research Protocol and Methodology Development

• Generative Studies

• Formative and Summative Usability Evaluation Studies

• Expert User Interface Evaluation

• Ergonomic and Design Audits

• Task Analysis

• Threshold Analysis

• Risk Management Principles

• Contextual Inquiry Methods

• Heuristic Evaluation

• Study Execution

o IRB Facilitation

o Subject Recruitment

o Research Facility – On Site Observation and Live Streaming