FDA Regulatory and Clinical Services for the Medical Technology Industry

Experience

The M Squared Associates team has experience with devices reviewed by every Division within FDA Center for Devices and Radiological Health (CDRH) Office of Device Evaluation (ODE), by the Office of In Vitro Diagnostics and Radiological Health (OIR), and by the Center for Biologics Evaluation and Research (CBER) Office of Cellular, Tissue and Gene Therapies (OCTGT).

CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH)

Office of Device Evaluation

Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices

Division of Cardiovascular Devices

Division of Ophthalmic and Ear, Nose, and Throat Devices

Division of Neurological and Physical Medicine Device

Division of Orthopedic Devices

Division of Surgical Devices

Division of Reproductive, Gastro-Renal, and Urological Devices

Office of In Vitro Diagnostics and Radiological Health

Division of Chemistry and Toxicology Devices

Division of Immunology and Hematology Devices

Division of Microbiology Devices

Division of Molecular Genetics and Pathology

Division of Radiological Health

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER)

Office of Cellular, Tissue and Gene Therapies