Your Partner for Rapid Clinical Product Development & Launch
Intune teams become an extension to your teams for the quickest path for IVD or medical device product development, analytical & clinical validation, regulatory approval and launch to your target markets.
Service & Capabilities
Our process starts with a deep understanding of the target user. Then we apply our suite of complementary and integrated IVD services to meet the demanding needs of the consumer-facing home-based OTC and point-of-care diagnostics and wellness devices.
Analytical and Clinical Research
with Full Regulatory Support
A full analytical and clinical research team with regulatory expertise providing the most accelerated path to FDA clearance for your IVD device or test. Our team has achieved multiple FDA authorizations, 510(k) clearances, and CLIA Waiver clearances and we will do the same for your medical device.
Full COVID-19 targeted services for FDA Emergency Use Authorizations (EUA) submissions for Point-of-care (POC) and Over the Counter (OTC) products, as well as de novo and 510(k) submissions
IVD Usability Testing & Human Factors Design
Intune incorporates usability testing and human factors design into the core of every IVD product to ensure they are used safely, integrate smoothly and perform the expected operations while providing the users with a delightful experience.