MDC Associates, Inc. is a trusted partner for Contract Research Organization (CRO) services, specializing in Data Management, Regulatory Affairs, and Quality Systems in the In Vitro Diagnostics (IVD) industry. The company offers comprehensive support for clinical studies, regulatory audits, quality management, and IVD market clearance, focusing on microbiology, clinical chemistry, infectious diseases, and diagnostic technologies. MDC Associates collaborates with startups, growing businesses, and established companies, providing tailored strategies, quality system development, regulatory guidance, and global network access. With over 35 years of expertise and a strong relationship with the FDA, they guide IVD makers through market clearance processes effectively and ensure compliance with regulatory standards.
regulatory • diagnostics • point of care • FDA • IVDR
October 1
Conducts clinical studies for IVD and medical devices with compliance oversight.
September 16
Lead regulatory projects and provide strategic guidance at MDC.
September 16
Drive business development for MDC's IVD and CRO services.