Founded in 1967 as a small medical device testing laboratory, NAMSA has grown to serve more than 3,000 companies each year, offering a full spectrum of medical device testing, preclinical and clinical research, and regulatory compliance consulting. The company is headquartered in Northwood, Ohio, United States, and is the world’s leading MedTech-focused Contract Research Organisation (CRO) and consulting firm.

As the first 100 per cent medical device-focused CRO in the world, NAMSA’s global end-to-end solutions are designed to help medical device companies overcome development hurdles, mitigate risk, and streamline their development efforts. The company operates under the backing of ArchiMed, a healthcare-focused private equity firm that acquired NAMSA in 2020. Since becoming an ArchiMed company, NAMSA has completed nine acquisitions, including the early development medical device testing business of Labcorp in January 2026 and the US medical device testing operations of WuXi AppTec.

Every year, more than 3,000 medical device and IVD companies worldwide trust NAMSA to help them bring innovative new products to market or ensure the ongoing safety of their existing products. The team of over 1,400 specialists is ready to support market research, preclinical studies, clinical trials, biological safety testing, regulatory submissions, and related activities. NAMSA works with a wide range of manufacturers, from start-ups developing their first device to multinational companies with thousands of SKUs.

With experts and laboratories located throughout the US, Europe, and Japan, NAMSA provides clients with direct access to local networks and regulatory expertise across key global markets.

Key Products and Services

Medical Device Testing

• State-of-the-art laboratories conducting over 118,000 biocompatibility, microbiology, sterility, and other tests annually, with all testing managed in-house to ensure direct oversight of test articles NAMSA
• Biocompatibility testing, microbiological testing, analytical chemistry testing, and extractables and leachables (E&L) studies; NAMSA conducts more than 70 per cent of all global biocompatibility studies NAMSA
• Efficacy and functional testing, materials characterisation, lot release testing, and sterilisation validation

Preclinical Research

• GLP-compliant and AAALAC-accredited preclinical laboratory facilities in the United States and Europe NAMSA
• In vivo and in vitro preclinical studies supporting regulatory submissions to the US FDA, EU Notified Bodies, and other global authorities

Clinical Research

• Full-service clinical trial management supporting every phase of testing, from first-in-human through pivotal and post-market studies, across technologies, therapies, indications, and geographies
• Adaptive study design, clinical hypothesis consultation, biostatistics, electronic data capture, and clinical data management
• Health economics and reimbursement planning, literature review, and staffing solutions for clinical development programmes

Regulatory and Quality Consulting

• Strategic consulting services spanning regulatory strategy to post-market support, including biological evaluation plans and reports, Clinical Evaluation Reports (CERs), FDA 510(k) and PMA submissions, QMS compliance, and Post-Market Clinical Follow-up (PMCF) surveys
• EU MDR and IVDR consulting and compliance support
• Market research and product development strategy

Reimbursement Consulting

• Pricing and reimbursement strategy consulting to help medical device companies navigate government regulations, customer demographics, and complex tender processes across international markets

NAMSA occupies a distinctive position in the MedTech services landscape as the only CRO focused exclusively on medical devices and IVDs. Its breadth of in-house capabilities — spanning laboratory testing, preclinical science, clinical research, and regulatory consulting — allows it to serve as a single integrated partner across the full product development lifecycle, reducing the fragmentation that typically arises when sponsors engage multiple specialist vendors. The company’s strategic outsourcing model and comprehensive in-house services are designed to help MedTech innovators mitigate risk, shorten time to market, and enhance stakeholder value. An active M&A strategy has progressively expanded its testing capacity and geographic footprint, reinforcing NAMSA’s position as the largest and most specialised CRO serving the global medical device industry.