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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 our unique expertise in human factors with years of experience in the medical field 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.
Usability Strategy & Plan
Gap Analysis
UOUP for MDR
Pre-submission  HF consulting

URRA - 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.
Use Specification
Task Analysis
URRA

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.
UI specification & design
IFU & labeling design
Risk control optimization

Formative and Summative Testing

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.
Formative evaluation
Summative testing
Usability File for MDR
HFE Report for FDA

Recruitment & Testing Facilities

Let us take care of all the required logistics, from participant recruitment to testing facilities, for seamless worldwide usability studies.
Global participant recruitment
User lab
Remote usability lab
Usability testing facility

Related Work

We have more than 15 years of experience designing interfaces for complex medical systems, and leading usability processes from start to finish.
All Projects

Tytocare

Telehealth revolution: Assuring safe use for FDA clearance

ReWalk

A step up for individuals with spinal cord injury

XACT Robotics

Shaping the future of precise biopsy with robotic innovation

Insightec

Redefining deep brain treatment with focused ultrasound
More Projects

Selected Usability Clients

From cutting-edge medical startups to established global biotech leaders, we proudly serve as a trusted usability partner.
All clients
All clients
"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.”
Michael Segev
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.”
Iddo Ambor
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