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Our History

a rich history of serving clients and advancing global patient healthcare




Global Associates


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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



Dr. Theodore Gorski, a scientist-entrepreneur, founded Science Associates. This company was incorporated to test materials used in medical devices and pharmaceutical containers.


Sportol® biological indicators were developed, the first of many in a line of sterility assurance products.



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.


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.


NAMSA expanded to Irvine, California to allow for same-day release testing.



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.



McMillan Research in Kennesaw, Georgia was acquired.


Biomatech was acquired in in Chasse-sur-Rhone, France to expand NAMSA’s European presence and medical device laboratory and consulting services.




NAMSA developed and sold its RSI product line of rapid read-out sterility indicators.


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.


Introduction of NAMSA’s medical device consulting practice, allowing clients to engage earlier in the product development process.


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.


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.



Alquest was acquired, a leading CRO specializing in regulatory consulting, clinical research and quality support.


The Integra Group was acquired to provide further preclinical, clinical, regulatory and research study capabilities.


Completion of the third and final phase of the expansion in Northwood, Ohio—the tenth expansion of all NAMSA facilities in many years.


Medvance, LTD, located in the United Kingdom, was acquired to expand clinical and consulting capacities across Europe.


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.


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.



French-based Archimed acquires majority interest in NAMSA.


In January 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.

In March 2021, 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.

In August 2021, NAMSA acquires Philadelphia-based CRO Clinlogix to enhance clinical therapeutic expertise and expand global footprint with four new locations throughout APAC, EU, North America and South America.


In March 2022, NAMSA acquires AKRN, a prominent European Medical Device CRO based in Madrid, Spain focusing on clinical and regulatory services for the medical device and diagnostic industries in Europe.

In March 2022, NAMSA announces its acquisition of Medanex Clinic, a Belgium-based European preclinical research organization. 

In October 2022, NAMSA acquires Perfectus Biomed Group, UK-based laboratory providing customized microbiological services to the MedTech industry.


In March 2023, NAMSA acquires SUAZIO, a Belgium-based strategic consultancy providing global market research services to medical device and IVD developers.

In July 2023, NAMSA acquires CRI, a German-based full service CRO providing the European MedTech market with complete clinical research solutions to accelerate scientific outcomes to clients.