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Services We Offer 

Judges Examining Document

Regulatory Compliance Assistance for US Laboratories to Navigate the FDA's Final Rule on Laboratory Developed Tests (LDTs)

  • Comprehensive LDT Assessment: We identify which of your tests are impacted by the phaseout policy and which are not.

  • Custom Regulatory Compliance Roadmap: Tailored strategies for each of your LDTs, including modified FDA-cleared IVD tests.

  • Procedure Implementation: Essential setup support for Corrections & Removals, Medical Device Reporting, and Complaint Handling procedures over the next 12 months for your LDTs (Stage 1).

  • Ongoing Support: From Stage 1 through Stage 5, we ensure your lab remains compliant.


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 one step closer to the market. Contact us for your specific needs.

Analyzing Data
Doctor Using Digital Tablet

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.

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