NAMSA

NAMSA is a contract research organization in Northwood, Ohio, that describes itself as 100% focused on medical devices and in vitro diagnostics.^[S4] It runs preclinical animal studies, biological safety testing under the ISO 10993 series, pathology, imaging and regulatory consulting, and it reports 1,650 medical device preclinical projects in the prior year.^[S4] The company traces itself to 1967, when Dr. Theodore Gorski founded Science Associates in Toledo, Ohio, to test materials used in medical devices and pharmaceutical containers.^[S1]

Services, as described by the company

Preclinical animal studies for devices

The named study categories are organized by anatomy and procedure rather than by drug development phase: cardiovascular and cardiothoracic, neurovascular, vascular, thrombosis and thromboresistance, hemostasis, orthopedic, dental, dermal, ophthalmic, pulmonary, gastrointestinal, urogenital, electrophysiology and wound healing studies.^[S4] The company states four laboratories offering preclinical services and 21 fully equipped operating rooms and catheterization laboratories.^[S4] The company states that four laboratories offer these services and that they include 21 operating rooms and catheterization laboratories.

Biological safety testing under ISO 10993

The biocompatibility panel covers genotoxicity under ISO 10993-3, hemocompatibility under -4, cytotoxicity under -5, implantation under -6, sensitization under -10, systemic toxicity under -11, chemical characterization under -18 and irritation under -23.^[S5] Systemic toxicity here is defined by the company as the generalized biological effects on organs and tissues following exposure to a device, a biomaterial, or their extracts.^[S5] Chemical characterization work under ISO 10993-18 is performed at an analytical laboratory in Obernburg, Germany, accredited to DIN ISO/IEC 17025:2018.^[S1]

Pathology, imaging and training

Histopathology and electron microscopy laboratories support the implant studies, with board-certified pathologists overseeing gross necropsy and interpreting histopathology.^[S4] An imaging core laboratory offers computed tomography, magnetic resonance imaging, micro-computed tomography, ultrasound and intravascular imaging.^[S4] The company also runs simulation-laboratory training for physicians and engineers on device use, and offers human factors and usability consulting.^[S4] Clinical research services, biostatistics, data management and regulatory consulting for the FDA and the European device regulations are listed separately.^[S3][S4]

GLP: the company's own pages do not agree

Two NAMSA pages describe the GLP position differently, and this profile does not resolve which is correct. The certifications table lists a Good Laboratory Practice certificate for two sites only, Diest in Belgium and Chasse-sur-Rhône in France, each marked as not expiring; the United States sites in that same table are listed with ISO/IEC 17025 accreditation, ISO 9001 certification, FDA ASCA participation and FDA registration, but no GLP certificate.^[S3] The preclinical services page separately describes GLP-compliant and AAALAC-accredited facilities in the United States and Europe, without naming which US sites or which regulation.^[S4] Neither page states whether the regulation intended is the FDA good laboratory practice regulation or the OECD principles.^[S3][S4] GLP compliance is in any case determined study by study rather than by facility,^[R2] so a sponsor should establish in the protocol which regulation the study will follow, at which site it will run, and that the final report will carry the study director's compliance statement and the quality assurance unit's statement.^[R2]

Quality, compliance, and animal welfare (as stated by the company)

The company states full accreditation by AAALAC International and lists dated certificates for four sites: Northwood, Ohio, issued November 22, 2024; Minneapolis, Minnesota, issued October 30, 2025; Diest, Belgium, issued June 11, 2025; and Chasse-sur-Rhône, France, issued June 13, 2025.^[S3] On the Animal Welfare Act it states only that it follows USDA regulations, without a registration number, site or date.^[S3] No OLAW Animal Welfare Assurance statement was found on the pages reviewed; that is an absence in those pages rather than a finding about the company. The company also states that it is registered with the FDA's drug and biologics centres, with distinct registration numbers by site, and describes focused inspections by the device centre under the quality system regulation at 21 CFR Part 820 and by the drug centre under the electronic records regulation at 21 CFR Part 11.^[S3] AAALAC International accreditation is a voluntary evaluation of an institution's animal care and use program, re-evaluated every three years,^[R3] and USDA registration and an OLAW Animal Welfare Assurance relate to the Animal Welfare Act and the PHS Policy respectively;^[R4][R5] none of these establishes GLP compliance, which applies to individual studies.^[R2] FDA does not approve or certify laboratories; registration with FDA does not denote approval.^[R6] This profile does not evaluate the animal care programme.

Ownership, acquisitions, and figures that do not match

A French investment firm, ArchiMed, acquired a majority interest in September 2020.^[S1] Since then the history page lists more than fifteen acquisitions since 1991, more than ten of them after that investment: the company's own history page lists more than fifteen acquisitions since 1991, more than ten of them after that investment.^[S1] Two recent ones changed the US footprint. The US medical device testing business of WuXi AppTec was acquired with completion on February 28, 2025, bringing the Minneapolis and Mendota Heights sites in Minnesota.^[S6] Select early development device testing assets of Labcorp were announced as acquired in January 2026.^[S1] Headcount is stated three different ways in company material: the about page carries both a figure of more than 1,400 scientists, technicians and consultants and a figure of more than 1,700 associates,^[S2] while the 2025 press release states more than 1,500 experts.^[S6] None is presented here as the correct figure.

Company facts