Usability Engineering in Medical Technology
Usability Engineering is a key success factor for safe, regulatory‑compliant, and economically successful medical devices. Learn how a standards‑compliant process based on IEC 62366‑1 reduces use‑related risks, satisfies Notified Bodies, and sustainably supports your MDR strategy.
The usability of medical devices is a central component of patient safety and regulatory approval. Within the framework of the usability engineering process according to IEC 62366-1, we support manufacturers in medical technology to systematically identify, evaluate, and minimize use-related risks.
From the use specification and formative evaluations to summative validation, we guide you in a structured, compliant, and practical way – tailored to your product, your target groups, and your MDR strategy.
Usability engineering for medical technology is much more than a usability test. For medical devices, it is a regulatory-required process for the systematic identification and minimization of use-related risks according to IEC 62366-1. Deficiencies in usability can not only endanger patient safety but also lead to delays in the approval process, additional studies, or critical inquiries from Notified Bodies. A structured and compliant usability engineering process creates security—technically, regulatorily, and economically.
The result: Robust usability evidence for Notified Bodies, reduced design iterations, and accelerated approval processes.
USE-Ing. supports you in the user-centered and MDR-compliant development of your medical devices:
- Use Specification & Context Analysis
- Identification of Use Errors & Hazard Situations
- Risk Analyses
- Planning & Execution of Formative Usability Tests
- Summative Usability Validation according to IEC 62366-1
- Recruitment of Healthcare Professionals (HCPs) and Patients
- Creation of Compliant Usability Documentation
- Support for MDR & Notified Body Requirements
Are you facing challenges in usability engineering or want to make your process fit for the next Notified Body audit? We look forward to welcoming you personally at MedtecLIVE 2026 – with fresh waffles and a professional exchange at eye level. Visit us in Hall 3, booth number 3-450d and speak directly with our experts.
