Usability for Medical Devices
Integrate the required usability engineering activities in your development process. Get your medical device approved by FDA / CE and bring it to the market.
Our Usability Services
We combine years of experience to ensure that your path to FDA or MDR clearance is as seamless as possible.
Planning & Strategy
Plan your usability activities early and devise a smart usability strategy which complies with regulatory requirements, while considering your project's resources and constraints.
Use-Related Risk Analysis
Rely on our expertise to bring the user perspective into your risk assessment. Identify and minimize use-related risks and ensure compliance with the latest FDA/MDR Human Factors guidelines.
Design for Medical Devices
Design a safe and innovative user experience for your medical product. Introduce risk mitigations by design and ensure your product meets the requirements of medical device design standards.
Evaluate the usability of your product throughout the development cycle. Use our expertise to plan and moderate test sessions, analyze the results and generate a thorough and concise report.
We have more than 15 years of experience designing interfaces for complex medical systems, and leading usability processes from start to finish.
"Cognit accompanied us in the process of designing our automatic injection device. Cognit’s professional team was involved in the details of the project as early on as the prototype stage, created an optimal use experience and led the usability testing in full compliance with FDA requirements.”
VP R&D and Design Engineering at Elcam Medical
“The experts from Cognit proved their ability to adapt to the client’s frame of mind while sensibly insisting on the right standards of user experience. Today they are an inseparable part of the development process. As a result, there is a proven improvement in the quality and ease of use of the software.”
Director of Software and System Development, Given Imaging
"Cognit put together a comprehensive usability testing program that allowed us to obtain very useful and valuable usability data on a prototype product, so we could make timely and effective business decisions. Their work was done well with a high degree of professional skill and competence.”
Edmond W. Israelsky, PHD
Director Human Factors at AbbVie
Connect with us to discover an exceptional experience