— OUR HISTORY — A RICH HISTORY OF SERVING CLIENTS AND ADVANCING GLOBAL PATIENT HEALTHCARE 0 FOUNDED 0 (1000+) ASSOCIATES 0 GLOBAL LOCATIONS DEVELOPING & DELIVERING NOVEL MEDICAL DEVICE TECHNOLOGIES SINCE 1967 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. NAMSA Founder, Dr. Theodore Gorski 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. OUR HISTORY 1960s 1970s 1980s 1990s 2000s 2010s 2020s 1960s 1967 Dr. Theodore Gorski, a scientist-entrepreneur, founded Science Associates. This company was incorporated to test materials used in medical devices and pharmaceutical containers. 1968 Sportol® biological indicators were developed, the first of many in a line of sterility assurance products. 1970s 1971 The founding name of ‘Science Associates’ was changed to ‘North American Science Associates, LLC’ (NAMSA); the company moved to its current corporate headquarters in Northwood, Ohio. 1976 The Medical Device Amendments to the Food, Drug and Cosmetic Act provided authority to the U.S. FDA to require that medical devices demonstrate safety and effectiveness prior to use in hospitals and clinics. 1977 NAMSA expanded to Irvine, California to allow for same-day release testing. 1980s 1986 Substantially informed by NAMSA’s biocompatibility matrix, the Tripartite guidance was introduced by a U.S. FDA official at a NAMSA-led seminar; this document formed the basis for ISO 10993-1. 1990s 1991 McMillan Research in Kennesaw, Georgia was acquired. 1995 Biomatech was acquired in in Chasse-sur-Rhone, France to expand NAMSA’s European presence and medical device laboratory and consulting services. 2000s 2001 NAMSA developed and sold its RSI product line of rapid read-out sterility indicators. 2002 Completion of the first phase of a 14,000 square-foot expansion plan in Northwood, Ohio to include new, dedicated spaces for a vivarium, toxicology laboratory and administrative building. 2004 Introduction of NAMSA’s medical device consulting practice, allowing clients to engage earlier in the product development process. 2005 Ceetox was acquired, providing sponsors with in-vitro toxicology screening tools to reduce, refine and replace the use of in-vivo models throughout medical device testing. 2006 Completion of the second phase of the expansion plan in Northwood, Ohio, including a 10,000 square-foot surgical center and a 15,000 square-foot addition to the toxicology facility. 2010s 2010 Alquest was acquired, a leading CRO specializing in regulatory consulting, clinical research and quality support. 2012 The Integra Group was acquired to provide further preclinical, clinical, regulatory and research study capabilities. 2013 Completion of the third and final phase of the expansion in Northwood, Ohio—the tenth expansion of all NAMSA facilities in many years. 2014 Medvance, LTD, located in the United Kingdom, was acquired to expand clinical and consulting capacities across Europe. 2018 Introduction of NAMSA’s ISO 10993-18 (DIN ISO/IEC 17025:2018 accredited) analytical testing laboratory in Obernburg, Germany for exhaustive extraction, FTIR, GC-MS, LC-MS and ICP-MS services throughout the EU. 2019 Acquisition of Reimbursement Strategies, LLC to provide expanded services in the areas of reimbursement, health economics and market access for the international medical device industry. 2020s 2020 French-based Archimed acquires majority interest in NAMSA. 2021 NAMSA acquires New York-based Syntactx, a leading Clinical Research Organization to enhance Electronic Data Capture (EDC), imaging core laboratory, and safety and physician consulting solutions. NAMSA acquires American Preclinical Services (APS) to provide Sponsors with a broader range of laboratory models and analysis tools, including innovative surgical instrumentation and several state-of-the-art catheterization labs, imaging capabilities and surgical suites. NAMSA acquires Philadelphia-based Clinical Research Organization Clinlogix to enhance clinical therapeutic expertise and expand global footprint with four new locations throughout APAC, EU, North America and South America. SUBSCRIBE TO NAMSA EVENTS NEWSLETTER SIGN UP JOIN THE NAMSA NETWORK Update your profile, post comments on the blog; sign-up for events, webinars and classes; receive email alerts and more. REGISTER Already have an account? Please Login Here NAMSA CLIENT PORTAL Login to the NAMSA Client Portal for sample submissions, testing reports, project tracking, and more. 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