Formative and comparative usability studies are conducted when there are unknowns in patient or caregiver performance. These studies identify use-related risks early in development and provide practical insight into how real users interact with your device.

We conduct structured, task-based research focused on expected use scenarios. Findings are translated into clear design recommendations, risk mitigations and documented evidence to support ongoing product development or comparison against existing devices.

This ensures usability risks are addressed proactively and development decisions are supported by robust user data.

Summative usability studies are performed when user performance is defined but requires confirmation prior to regulatory submission. These studies demonstrate that the device can be used safely and effectively by the intended users under expected use conditions.

We design and execute structured, risk-based evaluations aligned with applicable standards, including IEC/ISO 62366-1 and regulatory expectations such as FDA and EU MDR.

The outcome is comprehensive documentation suitable for submission, confirming that residual use-related risks are acceptable and adequately controlled.

Human Factors Validation Tests provide formal validation that the final device design supports safe and effective use. These studies are typically required for regulatory submission in the USA and other jurisdictions.

We conduct structured, risk-based validation testing under simulated use conditions with representative users. All critical tasks and identified use-related risks are assessed in accordance with regulatory guidance.

Deliverables include full validation reporting suitable for FDA and global submissions, providing confidence that the device meets human factors expectations.

Risk Management and Threshold Analyses support strategic decision-making, particularly for generics, combination products or device comparisons.

We assess use-related risks and design differences between reference listed devices (RLDs) and proposed products. Threshold Analyses determine whether differences are likely to impact safety or effectiveness and whether further human factors testing is required.

This service enables evidence-based regulatory strategy while minimising unnecessary testing.