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

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

FROM CONCEPT TO POST-MARKET, DELIVERING SIGNIFICANT TIME SAVINGS COMPARED TO INDUSTRY AVERAGES…

HELPING medical device SPONSORS IMPROVE HEALTHCARE SINCE 1967.

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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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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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March 18, 2021

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.

March 11, 2021

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.

March 02, 2021

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.

February 08, 2021

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.

January 18, 2021

U.S. FDA Releases Artificial Intelligence and Machine Learning Action Plan

In step with the U.S. Food and Drug Administration’s (FDA) commitment to develop and apply innovative approaches to the regulation of medical device software and other digital health technologies, on January 12, 2021, the Agency released their first Artificial Intelligence/Machine Learning (AI/ML) – Based Software as a Medical Device (SaMD) Action Plan.

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