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NAMSA

NAMSA IS THE WORLD’S LEADING MEDTECH CRO OFFERING GLOBAL DEVELOPMENT SERVICES

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DRIVEN BY ITS GLOBAL REGULATORY EXPERTISE AND IN-DEPTH THERAPEUTIC KNOWLEDGE

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FROM CONCEPT TO POST-MARKET, DELIVERING SIGNIFICANT TIME SAVINGS VS. INDUSTRY AVERAGES

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HELPING MEDICAL DEVICE SPONSORS IMPROVE HEALTHCARE SINCE 1967

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Our Services

Driven by our global regulatory expertise and in-depth therapeutic knowledge, NAMSA is a medical CRO offering only the most proven solutions to move your medical device through the development lifecycle as efficiently and cost-effectively as possible.

As a medical contract research organization, we are dedicated to helping you achieve accelerated, successful development and commercialization outcomes. NAMSA’s offerings include medical device testing; regulatory, reimbursement and quality consulting; and clinical research services.

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Resources

Learn from the world’s leading medical CRO with complimentary access to our latest white papers, webinars, and other resources to learn proven strategies and best practices for successful medical device development and commercialization outcomes.

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Blog

Always on the pulse of industry news, we interpret the latest regulatory guidelines and other medical device updates so you don’t have to. Learn from the world’s most trusted medical device CRO to stay up-to-date on recent news and what it means for your medical device development plans and commercial operations.

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MHRA Statement of Policy Intent: International Recognition of Medical Devices

Explore the crucial role of benefit-risk determination in EU MDR compliance and common pitfalls to avoid in medical device evaluation.

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An In-Depth Exploration of Reimbursement Billing Guides and Their Benefits

Explore the crucial role of benefit-risk determination in EU MDR compliance and common pitfalls to avoid in medical device evaluation.

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Understanding the Benefit-Risk Ratio in Clinical Reports: Avoiding 6 Common Mistakes

Explore the crucial role of benefit-risk determination in EU MDR compliance and common pitfalls to avoid in medical device evaluation.

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Preclinical Studies for Dental Bone Graft Devices - 510(k) Submissions

Explore FDA's 2006 draft guidance for dental bone graft device makers in our latest blog. Get insights on preclinical study requirements and 510(k) submissions.

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Understanding the New MDCG 2024-4 Guideline for IVD Safety Reporting

Learn about MDCG 2024-4 for IVD safety reporting and how NAMSA's expertise ensures compliance and patient safety in clinical studies.

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HAVE QUESTIONS?

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