Intune.bio is a service specializing in rapid clinical product development and launch, focusing on IVD and medical device development, analytical and clinical validation, regulatory approval, and market launch. Their suite of services includes IVD usability testing, human factors design, and full regulatory support for FDA clearances, including COVID-19 targeted services. They assist clinical laboratories in complying with FDA requirements for Laboratory Developed Tests (LDTs) by providing expertise in premarket notifications, quality system compliance, and FDA guidance, offering reliable, flexible, cost-effective, responsive, and supportive solutions.