Medical devices must demonstrate that they are safe, intuitive, and fit for use throughout their entire lifecycle. Under the Medical Device Regulation (MDR), this requires a structured and traceable usability validation documented in a comprehensive usability engineering file.
Consulteer supports a globally active manufacturer of ophthalmological medical devices in the evaluation of existing and new products. The goal is to create a usability documentation that meets national and international regulatory requirements while delivering tangible value for product development and end users alike.
Regulatory certainty meets real-world Use.
Medical devices in ophthalmology demand the highest levels of precision, safety, and ease of use. Multiple user groups, complex workflows, and real-world clinical conditions increase the risk of use-related errors.
The challenge was to systematically assess usability, identify potential risks early, and document all findings in full compliance with MDR requirements—without slowing down the development process.
Formative & summative Usability-Evaluation.
Recruiting the right user groups, building the right test setting, incorporating risk management, and formulating acceptance criteria: these are the quality features of our usability validations.
We validate the usability of the application of the medical device itself as well as accompanying materials, such as instructions for use and training materials.
Validating what matters in Practice.
A key success factor was the consistent application of high-quality validation standards:
Recruitment of appropriate representative user groups
Realistic and controlled test environments
Integration of risk management activities
Clear definition of acceptance criteria
In addition to the medical device itself, accompanying materials such as instructions for use and training documents were also validated. This ensured that the entire use system—product and information—functions safely and effectively.
Compliant. Practical. Future-ready.
Correct application of usability and human factors standards not only ensures regulatory compliance but also improves overall product quality. Insights gained during validation were directly fed back into product development, helping to further enhance usability and safety.
Consulteer bridges regulatory requirements and human-centered design. Our UX experts, product designers, and multidisciplinary teams work closely together to deliver medical devices that are compliant, intuitive, and ready for everyday clinical use - from evaluation through to complete documentation.
Together, we develop compliant medical and healthcare systems. Safe. Intuitive. Ready for real-world use.
