Diagnostic Developers

Diagnostic Developers, Inc. (DDI) is a specialized contract research and development organization (CRO) and contract development and manufacturing organization (CDMO) focused on the in vitro diagnostics (IVD) industry. Headquartered in Tustin, California, the company provides comprehensive services for the design, development, clinical validation, and regulatory clearance of diagnostic tests. DDI's expertise spans various technologies, including lateral flow assays, molecular diagnostics, and complex immunoassays. They support a global clientele, helping to transition innovative diagnostic concepts into market-ready medical devices. The company's expertise also extends to contract manufacturing, providing a turnkey solution for diagnostic startups and established healthcare firms alike. DDI is particularly noted for its ability to navigate the complex regulatory requirements of the FDA and other international health authorities.