Business Details
50+ Years
experience
Global Medical Device Testing & Regulatory Solutions
Namsa has been advancing medical device innovation and safety worldwide since 1967. Founded as Science Associates and later renamed North American Science Associates (Namsa), the company pioneered biological safety testing for medical devices and played a foundational role in developing international standards like ISO 10993. With over 1,400 specialists across the US, Europe, and Asia, Namsa offers integrated services spanning preclinical research, clinical trials, regulatory strategy, and post-market compliance. The company conducts 118,000+ medical device tests annually and supports 3,000+ manufacturers globally. Namsa's expertise covers 12 therapeutic areas, including cardiovascular, neurovascular, and orthopedics, with state-of-the-art GLP-compliant and AAALAC-accredited facilities.The organization maintains a 100% focus on medical device and IVD safety, combining deep technical knowledge with strategic regulatory insights. Namsa's acquisitions of companies like Alquest, Syntactx, and Perfectus Biomed have expanded its global footprint and service capabilities. The company emphasizes a holistic approach to device development, offering end-to-end solutions from concept to commercialization. With 55+ years of FDA engagement and 315 clinical/regulatory specialists, Namsa positions itself as the industry's only fully integrated medical device-focused CRO. The organization's commitment to innovation is demonstrated through its APEX PROGRAM, which provides detailed regulatory roadmaps to accelerate time-to-market while ensuring compliance.
Services
Biocompatibility Testing
Regulatory Consulting
Clinical Trials
Medical Device Testing
EU MDR Compliance
FDA Submissions
Preclinical Research
Market Research
Quality System Audits
Risk Management
Details
- Year established: 1967
Highlights and features
- 55+ years of specialized experience in medical device safety and compliance
- 1,400+ global specialists with therapeutic expertise across 12 medical fields
- State-of-the-art GLP-compliant and AAALAC-accredited laboratories in 6 countries
- End-to-end services from preclinical testing to post-market surveillance
- Proven track record with 3,000+ medical device manufacturers supported annually
Associations and certifications
- ISO 10993-18
- GLP-compliant
- AAALAC-accredited
- ISO 13485
Services
Biocompatibility Testing
Namsa conducts comprehensive biocompatibility testing to evaluate medical device safety through ISO 10993-compliant protocols. Our GLP-compliant laboratories perform chemical characterization, extractables/leachables analysis, and toxicological risk assessments. With 118,000+ tests annually, we help manufacturers demonstrate compliance with FDA, EU MDR, and global regulatory requirements while ensuring patient safety through rigorous biological evaluation plans.
Regulatory Consulting
Our regulatory consultants provide strategic guidance for FDA 510(k), De Novo, and PMA submissions with 500+ annual pre-submission meetings. We specialize in EU MDR/IVDR compliance, including clinical evaluation reports and post-market surveillance. With former FDA reviewers and Notified Body experts on staff, we deliver tailored regulatory roadmaps that accelerate approvals while maintaining compliance with evolving international standards.
Clinical Research
Namsa manages global clinical trials across all device classifications with expertise in cardiovascular, orthopedic, and diagnostic technologies. Our services include trial design, data management, biostatistics, and imaging core lab support. With experience in 320 annual clinical projects and a global network of investigative sites, we ensure trials meet regulatory requirements while maintaining patient safety and data integrity.
Quality Assurance
We offer comprehensive quality system services including ISO 13485 implementation, MDSAP compliance, and FDA mock audits. Our consultants help manufacturers establish robust quality management systems that meet 21 CFR Part 820 and EU MDR requirements. With 120 dedicated QA specialists, we provide risk management consulting, CAPA development, and regulatory remediation services to maintain ongoing compliance.
Market Research
Namsa's market research services support medtech commercialization through go-to-market planning, pricing strategy, and competitive analysis. With 1,700+ completed projects and a global HCP panel, we provide actionable insights for product positioning. Our services include patient journey research, usability testing, and economic stakeholder analysis to inform market access strategies and maximize commercial success.
People
Adam E. Saltman
Chief Medical Officer
Dr. Saltman leads Namsa's medical strategy with extensive experience in clinical research and regulatory affairs. He oversees the development of innovative testing methodologies and ensures alignment with global regulatory expectations. His leadership strengthens Namsa's commitment to advancing medical device safety through evidence-based approaches.
Wendy Schroeder
Principal Strategy Consultant
With over 20 years in clinical operations, Schroeder specializes in optimizing clinical trial execution for complex medical devices. She develops strategic frameworks that enhance trial efficiency while maintaining rigorous compliance standards. Her expertise improves client outcomes through practical, regulatory-aligned solutions.
Don Pohl
Principal Strategy Consultant
Pohl brings decades of experience in biocompatibility testing and regulatory compliance. He specializes in developing biological evaluation plans that meet evolving international standards. His technical expertise ensures clients receive practical solutions for complex safety assessment challenges.
Carla Wiese
Principal Regulatory Consultant
Wiese provides strategic regulatory guidance with particular expertise in FDA submissions and quality system compliance. Her deep understanding of regulatory pathways helps clients navigate complex approval processes efficiently while maintaining adherence to quality standards.
Kevin Butcher
Principal Regulatory Consultant
Butcher specializes in EU MDR/IVDR compliance with extensive experience in clinical evaluation reports and post-market surveillance. His background includes former Notified Body reviewer roles, providing unique insights into regulatory expectations for medical device approvals.
Questions
What services does NAMSA offer for medical device manufacturers?
NAMSA provides comprehensive services including biocompatibility testing, regulatory consulting, clinical research, quality assurance, and market research for medical device and IVD manufacturers.
How does NAMSA support FDA regulatory compliance?
NAMSA offers specialized FDA consulting services including 510(k) submissions, De Novo pathways, PMA applications, and pre-submission meetings with 500+ annual Q-Submissions managed.
What therapeutic areas does NAMSA specialize in?
NAMSA has expertise in 12 therapeutic areas including cardiovascular, neurovascular, orthopedics, in vitro diagnostics, wound care, and gastroenterology.
Does NAMSA have international capabilities?
Yes, NAMSA operates in 6 global locations across the US, Europe, and Asia with multilingual staff and compliance expertise in EU MDR/IVDR and other international regulations.
What makes NAMSA unique in the CRO industry?
NAMSA is the only 100% medical device-focused CRO offering integrated services from preclinical testing to post-market compliance with 55+ years of FDA engagement.
