For medical devices to be truly safe and effective, they must work, not just in theory, but in the hands of real users, in real environments. That’s where Human Factors Testing becomes essential. Usage errors and poor usability aren’t just inconvenient. They can result in harm to patients, delayed approvals, and increased legal exposure for manufacturers.

The Eurofins Medical Device Services network of laboratories specialises in the design and delivery of Human Factors Testing programmes that offer you real-world clarity early on in your development cycle, where it is most critical.

Our experts will test your products in the settings they’ll actually be used, whether that’s a home, hospital pharmacy, or operating room, by the people who’ll be using them, from clinicians to caregivers, emergency services personnel, or patients themselves.

Whether you’re evaluating instructions for use (IFUs), testing software interfaces, or validating complete drug delivery systems, our Human Factors Testing will:

• Assess the clarity and effectiveness of labels and IFUs
• Collect insight from both trained professionals and lay users
• Identify potential use-related errors early
• Simulate real use environments and workflows
• Support FDA compliance and usability standards

Integrating Human Factors into your device development strategy, combining user research, simulated-use studies, and usability evaluations that meet regulatory requirements will deliver practical, actionable insights. The result? Reduced risk, higher user satisfaction, and more potential for smoother submissions.

Testing can take place at any stage in the device lifecycle with approaches scaled accordingly. From formative evaluations to full summative validation studies, we offer both in-person and remote testing models, supporting hybrid workflows and international user panels.

• Customisable lab environments with adjustable lighting, sound, temperature
• Evaluation of the full user interface: packaging, documentation, training
• Guidance on protocol design, participant recruitment, and risk assessment
• Support for FDA-required Human Factors submissions
• Testing tailored to any stage: concept, development, or launch

When embedded early and revisited often, Human Factors Testing becomes a powerful tool to reduce development costs, minimise adverse events, and drive product success. It’s a critical component of the risk management process and one of the best ways to ensure your device performs safely, as intended, across its full lifecycle.

We support medical device and combination product developers of all sizes, from startups unfamiliar with regulatory expectations to multinationals facing increasing scrutiny on usability. Our dedicated project managers and usability experts will guide you through every stage, from planning to submission-ready reporting.

Human Factors Testing with Eurofins Medical Device Services will help you gain insight, foresight, and the confidence that your device can be used safely, effectively, and intuitively by everyone who needs it.