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.

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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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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October 11, 2021

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.

August 02, 2021

NAMSA ACQUIRES LEADING CLINICAL RESEARCH ORGANIZATION CLINLOGIX TO ENHANCE THERAPEUTIC EXPERTISE AND GLOBAL FOOTPRINT

NAMSA, the world’s only 100% medical device-focused Contract Research Organization (CRO) providing full continuum development solutions, announced today its acquisition of Clinlogix, a leading, Philadelphia-based global clinical research organization. Third in an advancing series, this acquisition follows NAMSA’s purchase announcements of Syntactx and American Preclinical Services (APS) in early 2021.

July 28, 2021

NAMSA First to Receive FDA ASCA Accreditation for Medical Device Biocompatibility Testing

Medical device and diagnostic manufacturers seeking acceleration of U.S. Food and Drug Administration (FDA) approval may benefit from one of two purpose-built FDA programs: 1) the Breakthrough Devices Program; and 2) the Safer Technologies Program (STeP). The benefits of these programs are substantial for manufacturers who apply, qualify and are granted designation by FDA.

June 07, 2021

FDA Breakthrough Devices and Safer Technologies Programs: Advantages for Patients and Medical Device Manufacturers

May 25, 2021

May 26, 2021: Marking a Regulatory Milestone for EU Medical Device Manufacturers

Today, the EU medical device industry reached a major milestone with the arrival of the extended application deadline for the European Union Medical Device Regulation (EU MDR 2017/745).

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