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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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MDCG Publishes New Guidance on Use of Standards Under MDR/IVDR

On April 16, 2021, the Medical Device Coordination Group (MDCG) published “Guidance on Standardisation for Medical Devices” (MDCG 2021-5).

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FDA CDRH Announces New Resource for Medical Device Biocompatibility Assessments 

The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced on March 18 that it is now offering  an electronic Biocompatibility Assessment Resource Center intended to provide guidance for addressing and evaluating the biocompatibility of medical devices. 

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NAMSA Begins Next Chapter of Growth under Newly Appointed CEO, Dr. Christophe Berthoux

NAMSA®, the world’s only 100% medical device-focused Contract Research Organization (CRO) providing full continuum development solutions, announced today its executive leadership transition plan with the appointment of Dr. Christophe Berthoux as NAMSA’s new CEO, effective March 22, 2021.

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NAMSA Acquires American Preclinical Services

NAMSA, the world’s only 100% medical device-focused Contract Research Organization (CRO) providing full continuum development solutions, announced today its acquisition of Minneapolis-based American Preclinical Services (APS), a full service preclinical CRO. This purchase follows NAMSA’s acquisition of New York-based Syntactx, a leading clinical research services CRO, in January 2021. 

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Effective March 15: CMS Rule Regarding Medicare Coverage of Innovative Technology (MCIT) and Definition of 'Reasonable and Necessary'

On January 14, 2021, the Centers for Medicare & Medicaid Services (CMS) released the Final Rule, “Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘Reasonable and Necessary.” As part of Medicare’s Patients over Paperwork initiative, This final rule regulates how the largest U.S. federal payer will reimburse for innovative technologies, beginning March 15, 2021.

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