Intuitive Minds. Human Design.

Conduct Formative and Summative human factors evaluations with FDA guidance.

• FDA Guidance on Applying Human Factors and Usability Engineering to Medical Devices (2016)

• FDA Draft Guidance on Content of Human Factors Information in Medical Device Submissions

• IEC 62366-1:2015 (Usability Engineering Process)

• ANSI/AAMI HE75 (Human Factors Design Principles)

• ISO 14971:2019 (Risk Management)

Usability testing for AI applications & robotic devices to ensure seamless integration and user-friendly interfaces.

• Analysis of user performance, errors and subjective feedback

• Detailed task and scenario analysis for critical user interactions

• Risk prioritization and mitigation with recommendations for UI enhancements and risk controls

• Alignment with ANSI/AAMI HE 75 design principles

• Documentation supporting formative insights and regulatory risk management

Evaluate the usability of combination products to meet regulatory standards and improve patient outcomes.

• Simulated-use formative testing tailored to patient self-administration

• Identification for common use errors (e.g., dose selection materials, inadequate priming, poor breath hold/coordination) and root causes

• Feedback on instructions for use (IFU), packaging, labeling and training materials

• Use-related risk mitigation strategies aligned with IEC 62322, ISO 14971, and FDA's Safety Considerations for Product Design to Minimize Medication Errors