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NAMSA

NAMSA is the World’s Only 100% Medical Device-Focused CRO offering global end-to-end development solutions…

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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 COMPARED TO 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 offers only the most proven solutions to move your medical device through the development lifecycle as efficiently and cost-effectively as possible.

Offering product development strategy; medical device testing; regulatory, reimbursement and quality consulting; and clinical research services, we are dedicated to helping you achieve accelerated, successful development and commercialization outcomes.

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Resources

Gain 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 what recent news means for your medical device development plans and commercial operations.

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NAMSA Expands Minneapolis Preclinical Laboratory to Meet Industry Demand for Medtech Research and Development Solutions

NAMSA, the world’s leading MedTech Contract Research Organization (CRO) offering global end-to-end development services, announced today the expansion of its Minneapolis preclinical research laboratory. This expansion will add 55,000 sq. ft. to the current 130,000 sq. ft. preclinical campus in Minneapolis.

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FDA Releases Draft Guidance: Content of Premarket Submissions for Device Software Functions

In step with the U.S. Food and Drug Administration’s (FDA) commitment to develop a draft revised version of “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” (2005), the agency, on November 3, 2021, has issued draft guidance—“Content of Premarket Submissions for Device Software Functions.”   

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Interventional Oncology: Fast Forward to the Future

As cancer has surpassed cardiovascular diseases and is now the leading cause of death worldwide, its conquest remains elusive despite recent notable progress. Cancer remains an incredibly complex disease, involving virtually every tissue in the body and affecting many genes.

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MDCG Publishes New Legacy Device Guidance 2021-25

Following the release of the Medical Device Coordination Group (MDCG) guidance 2021-24 on 4 October, 2021, MDCG published additional guidance, MDCG 2021-25 Regulation (EU) 2017/745, dated 21 October, 2021.

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MDCG Releases Guidance on Classification of Medical Devices (MDCG 2021-24

On 4 October 2021, the Medical Device Coordination Group (MDCG) released the long-awaited guidance document (MDCG 2021-24) on classification of medical devices under MDR 2017/745.

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