Discover the power of iYou health: the most affordable and reliable partner in the bringing your newly manufactured devices to market. With us, you can rest assured that your clinical trial is in the best of hands. Experience the ease and confidence of working with the top-of-the-line.‎ iYou Health Grow Your Vision iYOU Health is a subsidiary of XYZ Health Group, LLC. As a CRO company, our mission is to help manufacturers around the world to bring their IVD products ‎to the US、EU and other international markets in a timely manner‎ About Us We Provide Regulatory Compliance Supports An alytical Testing Clinical Studies Contact us for more information on how can we assist you. Start Now

Services We Offer Regulatory Compliance Supports ​ We will help you evaluate the specifics of your medical product, prepare for the pre-submission, communicate with the FDA, finalize the st udy protocol, file for IRB approval, perform analytical tests and clinical studies, prepare for final submission and provide post-market support. Contact us for your specific need Analytical Testing ​ Equipped with direct access to CLIA-certified, CAP-accerdited and GLP-compliant high complexity laboratories and experts in laboratory science and technology, we are ready to perform analytical performance evaluations for your product to meet regulatory requirements. We can also help you with research and development to bring your great idea on e step closer to the market. Contact us for your specific needs. Clinical Studies ​ If your product requires clinical trials, including usability studies, iYou Health can assist you at any stage of the process. Our services range from selecting suitable clinical sites, drafting protocols, and preparing research materials to obtaining IRB approval, recruiting participants, conducting clinical studies, and drafting the study report. Please contact us to discuss your specific needs.

About Us With direct access to CLIA/CAP-certified, GLP-compliant high complexity laboratories, and GCP-compliant clinical investigation sites, and led by a management team with decades of biomedical research experience, regulatory affairs expertise, and international clientele experience, iYou Health is your ideal partner to bring your medical product from R&D to market approval. Who We Are iYou Health strives to be the most affordable and reliable partner in bringing your product from the manufacturer to the market. Our CRO team has the knowledge in planning in-vitro diagnostic device clinical trials across the United States. Equipped with a powerful FDA CFR 21 Part 11 compliant digital clinical trial management systems (CTMS). We ensure patient protection and regulatory compliance throughout the entire monitoring, auditing, training, project management, and safety monitoring process.

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