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Telehealth Revolution: Assuring Safe Use for FDA Clearance
Overview
Usability testing for a remote medical exam device
TytoCare is an innovative home-use device, enhancing diagnosis and care from the comfort of home. Cognit supported its usability testing process, as required for FDA clearance. We have performed both formative and summative usability studies for TytoCare, in Israel and in USA, as part of the development efforts and regulatory requirements. The summative evaluation report and accompanying materials have been submitted and the product subsequently approved by the FDA.
Usability Testing
HFE Validation Test
Medical Devices
Home Use
Expert Evaluation
"During the process, it was crucial to adhere fully to the FDA usability evaluation guidelines, while continuously providing the development team with feedback and recommendations, to optimize product design. It is immensely rewarding to witness TytoCare's widespread trust among over 180 healthcare organizations worldwide, as it continues to empower individuals and families to access high-quality care from the comfort of their own homes".
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