M Squared Associates provides FDA regulatory, clinical research (CRO) and quality systems consulting services to domestic and international medical device companies. Our full time staff includes experienced professionals from the medical device industry and from FDA. Our core strength is developing and executing project strategies that meet each individual client's business objectives for introducing new products to US and international markets.

Medical Devices Biotechnology US Food and Drug Administration (FDA) Regulatory Strategy PMA IDE De Novo HDE 510(k) Registration and Listing US Agent CRO Clinical Trials Biostatistics Clinical Study Management Data / Database Management Quality Systems ISO 13484 Design Controls Medical Writing Software as a Medical Device Due Diligence Medical Equipment Medical and Hospital Equipment