Since 2001, M Squared Associates has provided a full range of regulatory, quality and clinical consulting services to US and international medical technology firms. We specialize in devices and combination products that are reviewed by FDA's Center for Devices and Radiological Health (CDRH). Our corporate culture fosters innovative thinking; we thrive on the complicated and complex regulatory challenges commonly associated with ground-breaking technologies.
We take care to understand each client's US and global business objectives to assure that the regulatory strategy complements and supports plans for commercialization.