Testing labs in Chasse Sur Rhone

ISO/IEC 17025 accredited by COFRAC (No. 1-7369) testing laboratory (accreditation status: active). Accredited test areas include: Chemical Spectroscopy; Water Environmental. Located at 38670, Chasse Sur Rhone, France.

NAMSA (North American Science Associates) is the world's preeminent medical device Contract Research Organization (CRO), established in 1967 and headquartered in Northwood (Toledo), Ohio, USA. As the acknowledged pioneer of the medical device testing industry, NAMSA has spent more than five decades building the most comprehensive, fully integrated development and testing infrastructure dedicated exclusively to medical devices and in vitro diagnostics (IVDs). More than 3,000 medical device and IVD companies worldwide trust NAMSA annually, relying on its end-to-end offering that spans laboratory testing, preclinical research, regulatory consulting, and clinical trial support under one roof. At the core of NAMSA's capabilities is a suite of more than 200 validated medical device test methods executed across seven highly sophisticated laboratory facilities located in the United States and Europe. The organization conducts in excess of 118,000 biocompatibility, microbiology, sterility, and ancillary tests per year. Each testing program is structured around the specific regulatory pathway of the device under evaluation—whether a U.S. FDA 510(k) clearance, PMA approval, or CE marking under the EU Medical Device Regulation (MDR)—ensuring that data packages are scientifically defensible before the U.S. FDA, European Notified Bodies, Japan's PMDA, and other global regulatory authorities. Biocompatibility assessment is one of NAMSA's flagship competencies and the area in which it has earned its most significant regulatory distinction. The organization executes the complete ISO 10993 series of biological evaluation tests, including ISO 10993-5 (cytotoxicity), ISO 10993-4 (hemocompatibility), ISO 10993-6 (implantation and histopathology evaluated by a Board Certified Pathologist), ISO 10993-10 (sensitization via both in vivo and in vitro methods), ISO 10993-11 (systemic toxicity), and ISO 10993-18 (chemical characterization, extractables and leachables). NAMSA also authors Biological Evaluation Plans (BEPs) and Biological Evaluation Reports (BERs) required under ISO 10993-1, and conducts genotoxicity studies and toxicological threshold assessments, providing sponsors with a single scientific and documentation source for their entire biological evaluation program. NAMSA's sterility assurance and microbiology practice addresses every major sterilization modality recognized under ISO 11135, ANSI/AAMI, and related international standards. Sterilization validation services cover gamma radiation, electron-beam irradiation, ethylene oxide (EO) gas sterilization, hydrogen peroxide vapor sterilization, moist-heat sterilization, and dry-heat sterilization. Supporting analytical services include bioburden testing per ISO 11737-1, growth promotion testing, EO residual and degradation product quantification, and sterility testing conducted in ISO Class 5 controlled environments. Dedicated cleanrooms and environmental aging chambers support the full scope of sterility assurance testing for regulated medical device manufacturers. Beyond laboratory services, NAMSA operates GLP-compliant and AAALAC International-accredited preclinical research facilities in the United States and Europe, conducting in vivo studies—including implantation, chronic toxicology, and device performance evaluations—under 21 CFR Part 58 Good Laboratory Practice regulations and applicable ISO and ASTM standards. These capabilities allow sponsors to obtain pivotal non-clinical safety data required for regulatory submissions from a single partner. NAMSA has further strengthened its preclinical platform through the acquisition of American Preclinical Services (APS), expanding its depth in interventional and surgical device research. NAMSA's quality credentials are anchored by ISO/IEC 17025:2017 laboratory accreditation and ISO 9001:2015 certification. Most significantly, NAMSA was the first—and remains the only—laboratory in the United States to receive accreditation under the FDA's Accreditation Scheme for Conformity Assessment (ASCA) program for medical device biocompatibility testing, a regulatory designation that expedites FDA review of device submissions relying on NAMSA-generated data. The organization is registered with both the CDER and CBER divisions of the FDA, and its facilities have been subject to inspection under 21 CFR Part 820 quality system regulations. NAMSA's test results carry global recognition and are accepted by regulatory agencies across North America, Europe, and Asia. NAMSA also delivers comprehensive regulatory and quality consulting services, including U.S. FDA strategy and submissions (510(k), PMA, De Novo, IDE), EU MDR and IVDR compliance, Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-up (PMCF) programs, Human Factors studies, and Quality Management System (QMS) implementation. Clinical trial design, site management, and data management services complement the laboratory offering, making NAMSA one of the few organizations capable of accompanying a medical device from early-stage concept through post-market surveillance. For any medical device or IVD sponsor seeking a single, expert, internationally recognized testing and development partner, NAMSA's combination of exclusive focus, six-decade track record, ASCA-accredited biocompatibility laboratory, GLP-compliant preclinical facilities, and global regulatory consulting expertise represents a uniquely integrated and credible choice.