NAMSA
About Company
In 1967, a glass manufacturer in Toledo, Ohio approached a clinical laboratory to test polymeric materials for pharmaceutical container testing. While the clinical lab passed on the work, Dr. Theodore Gorski, a scientist-entrepreneur, recognized the opportunity and accepted the project. 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.
Over the last several years, while regulations have continued to evolve and become more complex, NAMSA has proudly played an integral role in developing domestic and international standards for testing medical devices, materials and In Vitro Diagnostic (IVD) products. In addition to medical device laboratory testing, NAMSA’s services have grown to include regulatory, reimbursement and quality consulting, as well as clinical research solutions. These additions have helped NAMSA become the industry’s only 100% medical device-focused Contract Research (CRO) organization that offers proven, strategic solutions throughout the full development continuum to allow Sponsors to fast-track commercialization efforts, while achieving time and cost efficiencies, in every major market of the world.
