Usability
Usability in Focus – Together with Our Partner Use-Lab
Safe and effective operability of medical devices is a key regulatory requirement – firmly anchored in the MDR and the standard IEC 62366-1. A systematic usability evaluation ensures that products are intuitive to use and that potential use errors are identified early and minimized.
As we do not offer this highly specialized service ourselves, we work closely with Use-Lab GmbH, an experienced and internationally active partner for usability engineering in the medical device sector.
Services Provided by Use-Lab
Use-Lab GmbH conducts standards-compliant and practice-oriented usability evaluations for our clients – from early-stage planning to fully regulatory documentation:
- Requirements and context analyses to define user needs early in the process
- Formative usability testing to iteratively optimize design and user guidance
- Summative usability evaluations for final validation according to IEC 62366-1
- Marketing claim substantiation studies to support product and competitive claims
- Use error analysis and identification of risk-prone interactions
- Recruitment of real target users and execution of moderated test scenarios
- Regulatory documentation for FDA submissions (Human Factors Engineering Report) or CE marking (Usability Engineering Report)
- Consulting on the development of user-centered interfaces
- Standards-compliant creation and evaluation of Instructions for Use (IFU)
Use-Lab operates state-of-the-art testing facilities at its own site – including simulation rooms for surgical or nursing environments – and combines interdisciplinary expertise in psychology, human factors engineering, and medical technology. In addition to on-site studies, Use-Lab also conducts research across Europe and worldwide, with a strong focus on the U.S. market.
