At DeSia, we provide comprehensive usability engineering services to ensure that your medical device is safe, effective, and intuitive for its intended users. Our approach complies with the EN/IEC 62366-1 standard and supports the integration of usability into your overall design and risk management process.
What we offer
- Formative usability evaluation: Planning and conducting early-stage assessments to identify potential use errors and inform design improvements
- Summative usability evaluation: Executing final validation studies with representative users to demonstrate safe and effective use under expected conditions
- Usability protocol development: Preparing structured, objective protocols tailored to the device, user group, and intended use environment
- Study design and execution: Organizing and managing test sessions, including participant recruitment, data collection, and analysis
- Usability reporting: Documenting study methods, findings, and conclusions in compliance with regulatory expectations
We support both standalone usability evaluations and integrated studies as part of the design validation process. Our team ensures all human factors data are traceable, justified, and aligned with risk management documentation and technical files.
Do you need support with your usability engineering process? Book your complimentary initial consultation.
