NAMSA is a global medical research organization. We help medical device companies get their devices to market sooner which improves patient lives around the globe.
NAMSA started in 1967, by Dr. Theodore Gorski. Dr. Gorski saw a need to test polymeric materials for pharmaceutical container testing. By following methods outlined in the United States Pharmacopeia, he successfully performed the requested testing and soon thereafter, Dr. Gorski established Science Associates, a Contract Research Organization (CRO) focused on medical device and materials testing.
Nearly a decade later, the United States Congress authorized the U.S. FDA to regulate medical devices. By that time, North American Science Associates (NAmSA) had already developed a testing matrix to assure biological safety of medical devices and materials, which was later incorporated in to the Tripartite Guidance, TC194 and is part of today’s ISO 10993 requirements.
NAMSA has transformed over the years to become the World's first Medical Research Organization. NAMSA has proudly played an integral role in developing domestic and international standards for testing medical devices, materials and In Vitro Diagnostic (IVD) products.
NAMSA’s services have grown to include regulatory, reimbursement and quality consulting, as well as clinical research solutions.
Our culture is one of quality, integrity, collaboration, kindness, helping others, and learning.