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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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What is the Difference Between SiMD and SaMD?

Learn the key differences between SaMD and SiMD, and how the FDA's evolving guidelines impact the MedTech industry and healthcare outcomes.

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Qualification and Classification of Software Under the EU Regulations MDR and IVDR

Learn how Medical Device Software (MDSW) is classified under EU MDR and IVDR regulations. Understand definitions, rules, and compliance steps.

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FDA’s Regulation of AI/ML SaMD

Explore the differences in medical device software regulations between the EU's MDR and the US FDA, including SaMD, SiMD, and cybersecurity guidance.

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Comparing US FDA vs EU MDR Medical Device Software Requirements

Explore the differences in medical device software regulations between the EU's MDR and the US FDA, including SaMD, SiMD, and cybersecurity guidance.

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Bioburden Testing vs. Sterility Testing: What Is The Difference?

Bioburden testing quantifies living microorganisms on medical devices pre-sterilization, while sterility testing confirms their absence post-sterilization. Both are vital for patient safety and product efficacy.

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HAVE QUESTIONS?

Let NAMSA’s medical device development experts guide you in the right direction.