About Us
iYou Health is led by a management team with extensive experience in biomedical research, regulatory affairs, and international client management. With direct access to CLIA/CAP-certified, GLP-compliant high-complexity laboratories and GCP-compliant sites, we are the perfect partner for transitioning your medical product from R&D to market approval. Our expertise in LDT development, operational management, and FDA compliance ensures we can effectively guide your laboratory through the phaseout process, ensuring full compliance with the FDA’s final rule on LDTs.
Who We Are
iYou Health is committed to being the most affordable and reliable partner for transitioning your products from manufacturing to market. Our CRO team is well-versed in planning in-vitro diagnostic device clinical trials throughout the United States, backed by a robust FDA CFR 21 Part 11 compliant digital Clinical Trial Management System (CTMS). This ensures patient protection and regulatory compliance across all facets of monitoring, auditing, training, project management, and safety monitoring.
Our scientific management team brings decades of experience in LDT development and operational management, coupled with deep knowledge of FDA regulatory affairs. As the FDA implements its final rule on LDTs, we are dedicated to guiding your laboratory through the complex phaseout process, ensuring you remain fully compliant with FDA regulations.