Research & Development
Usability Engineering.
Safety through excellent usability. We support medical device manufacturers in the full implementation of usability engineering in accordance with IEC 62366-1—from formative evaluation to summative studies.
What usability challenges arise in the medtech development process?
IEC 62366-1:2015 calls for rigorous usability processes, but in practice there are often significant shortcomings:
- Usability is not integrated into the development process from the outset, but is instead hastily added shortly before submission.
- Usage error analyses (UEVA) are incomplete and do not cover critical "worst-case" usage scenarios.
- Summative evaluation studies are methodologically flawed and do not provide designated bodies with reliable data.
- Without a structured Usability Engineering File (UEF), MDR compliance for the product is effectively impossible to demonstrate.
Is your usability engineering file fully documented and completely ready for review by the Notified Body?
Our usability engineering services.
We do not view usability as a burdensome compliance hurdle, but rather as an essential tool for safety and quality.
Usability Process Framework (IEC 62366-1)
Methodological design of the entire process: definition of the intended use, identification of use scenarios and the intended user profile. Detailed task analysis and identification of hazard-related use scenarios.
Formative Evaluation & Iterative Testing
Conducting formative usability tests in early stages (e.g., expert reviews, cognitive walkthroughs, prototype tests) to facilitate early, iterative improvements to the product design.
Summative evaluation (validation study)
Rigorous planning and execution of the final summative evaluation with a fully representative sample of users. This includes the creation of test protocols, test scenarios, and the final usability evaluation report.
Usability Report & MDR Documentation
Complete development and critical review of the Usability Engineering File (UEF). Seamless integration of usability results into the IFU, risk management, and technical documentation in accordance with the MDR.
Frequently Asked Questions About Usability Engineering.
What exactly does IEC 62366-1 require?
The standard defines a structured process for minimizing risks associated with user errors. At its core, it involves a systematic preliminary analysis of potential "use errors" and empirical evidence (evaluation) that the product design reliably prevents these risks or reduces them to an acceptable level.
What is the difference between formative and summative assessment?
Formative evaluations are small, iterative tests conducted during the development process—they identify design flaws so they can be corrected immediately. Summative evaluation is the rigorous, final validation study conducted on the finished design with real users. It formally confirms the design’s safety and usability.
When is a usability study with patients absolutely necessary?
Whenever a medical device is used directly by patients or non-medical personnel (e.g., family members) and the hazard analysis identifies serious risks in the event of an operating error (hazard-related use scenarios). For products intended solely for professional use, testing by qualified personnel is sufficient.
How are IEC 62366 and ISO 14971 related?
They are inextricably linked. Usability risks (use errors) are an integral part of risk management (ISO 14971). Usability findings are incorporated into the risk analysis, and conversely, the risk assessments precisely define the critical "hazard-related" scenarios that must be tested in the usability study.
Related Engineering & Compliance Topics.
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