Why Usability Testing is Essential for Medical Devices
Usability Testing is a cornerstone of safe and user-centered medical device development. It enables teams to identify and resolve design issues, prevent use errors, and validate that devices can be used safely and effectively by the intended users in real-world conditions.
In accordance with IEC 62366-1 and FDA guidance, usability testing ensures that user interface-related risks are systematically identified and mitigated. It strengthens regulatory submissions and reduces costly design iterations late in development.
Detects use errors before market release
Enables evidence-based design improvements
Satisfies IEC 62366-1 and ISO 14971 requirements
Supports FDA-compliant Human Factors Validation
Provides audit-ready documentation
Two Key Types of Usability Testing
Usability testing is a regulatory requirement for medical devices intended for most global markets, including under IEC 62366-1, ISO 14971, NMPA- and FDA Human Factors Engineering Guidance. Its purpose is to ensure that the device’s user interface supports safe and effective use by intended users, in the intended context of use, without introducing unacceptable use-related risks.
As part of a structured Usability Engineering Process, manufacturers must plan, execute, and document usability evaluations at key stages of development.
Formative Usability Testing
Performed iteratively throughout development, formative tests identify usability problems early and guide design improvements. They are crucial for shaping an intuitive and safe user interface. Conducting these tests with an independent external team is strongly recommended by studies. It is often more effective, as external evaluators bring fresh perspectives, reduce internal bias and are more likely to uncover use-related risks that internal teams may overlook.
Summative Usability Testing (Validation)
Also known as usability validation, summative testing demonstrates that the device can be used safely and effectively by intended users. It is required for regulatory approval and must follow a structured, documented process.
Our Usability Testing Services
We support you in planning, executing, and documenting both formative and summative usability tests as part of a compliant Usability Engineering process. Whether you're conducting early design evaluations or preparing for regulatory validation, we adapt to your specific needs and can step in at any stage of your development. From test planning and recruitment to moderation, analysis, and audit-ready documentation, we provide flexible, expert support that aligns with IEC 62366-1, MDR/IVDR, NMPA and FDA Human Factors requirements - ensuring your device is not only compliant, but also safe, intuitive, and ready for real-world use.
Goal: Improve usability and reduce risk during development.
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Test design and protocol development
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Recruitment of target users
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In-person or remote test execution
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Observation, moderation, and analysis
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Reporting and input for design iteration
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Goal: Provide regulatory proof of safe and effective use.
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Validation plan development (IEC 62366-1, FDA)
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Definition of Hazard-Related Use Scenarios
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User recruitment and screening
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Test setup and execution in realistic environments
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Use error analysis and validation reporting
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Goal: Ensure traceability and audit readiness.
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Evaluation plans for formative and summative tests
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Risk-based scenario selection
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User Interface Specification review
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Structured reporting and integration into the Usability Engineering File
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Goal: Integrate usability-related risks into overall risk management.
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Mapping of use errors to critical tasks
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Support in ISO 14971 risk assessments
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Planning of usability-related risk control measures
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Traceability to design and labeling decisions
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Your Benefits from structured and effective Usability Testing
Fewer use errors
and safer products through early detection
Faster development
by avoiding costly rework
Stronger regulatory compliance
with IEC 62366-1, MDR/IVDR and FDA HFE Guidance
Higher user acceptance
through evidence-based design decisions
Everything about Usability and UX for Medical Devices
Explore our full range of services across the entire usability engineering process. Whether you need targeted support in a specific phase or guidance throughout the full development cycle – our services adapt to your needs. Learn more about each offering and find the right support for your project.
Usability Engineering
Design medical devices that are safe, intuitive and compliant. We guide you through the usability engineering process – from concept to submission.
User Research
Understand real user needs and reduce risks early. We uncover insights that lead to better medical products.
UX/UI Design
Make complex technology easy to use. We design intuitive interfaces for medical devices and digital health solutions.
Whether for creating an intuitive user interface or meeting regulatory requirements for demonstrating safe use – usability testing is a key component in the development of medical devices.