Human Factors Engineering
for regulated medical products

Helping medical device teams design, test, and validate safer, compliant products.

MEDICAL DEVICE HUMAN FACTORS STRATEGY

Human factors strategy, usability testing, and validation to support the safe and effective use of regulated medical devices and device systems.

MEDICAL DEVICE HUMAN FACTORS ENGINEERING

End-to-end human factors engineering for medical devices, from formative research through summative validation.

SOFTWARE & AI HUMAN FACTORS ENGINEERING

Usability and risk-focused design for healthcare software, digital health tools, and AI-enabled medical systems.

ISO 13485 certified

10+ years experience

Global regulatory expertise
(EU MDR, FDA)

Medical devices, pharma & healthcare software

Total Compliance™ solutions

Support for regulated medical devices where compliance, validation, and submission-readiness are critical. We help ensure your product, documentation, and usability evidence meet global regulatory expectations.

Includes:

Readability Studies
Human Factors Validation Tests
MDR / IVDR Compliance (IEC 62366-1 Annex C)

Individual Usability™ solutions

Targeted usability studies designed to evaluate real-world use, identify risk, and confirm safe and effective interaction with your device across its lifecycle.

Includes:

Formative or Investigational Usability Studies
Actual Use and Summative Usability Studies

Human Factors Intelligence™ solutions

Insight-driven research to understand user needs, behaviours, and expectations before design decisions are locked in. These studies inform strategy, design direction, and development priorities.

Includes:

Ethnographic Research
Medical Market Research

User Centric Design Solutions

Design and development support focused on user-facing materials and interfaces. We help translate requirements and insights into clear, usable, and compliant outputs.

Includes: