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NAMSA

NAMSA is the World’s leading medtech cro offering global end-to-end 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 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 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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U.S. FDA Emergency Use Authorization: CRO Lessons Learned for the MedTech Industry

During the COVID-19 Pandemic, the FDA CDRH put the hardest, longest and most intensive work into reviewing EUA applications for COVID-19 diagnostic tests. The result was a shift in how the FDA, MedTech manufacturers and CROs conduct work, which is still in place today. 

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Health Canada and FDA eSTAR Pilot

On January 10, 2023, the U.S. Food and Drug Administration (FDA) and Health Canada announced a new joint pilot program. This program will conduct tests on the use of FDA’s eSTAR to make a single medical device submission to both FDA and Health Canada.

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The Value of Economic Data in Payor Engagement

Economic data can be any data that tells a utility or benefit story. It can include health economics and outcomes research (HEOR) which measures and generates evidence of a product’s value and impact to support reimbursement and market access. But, for purposes of this blog post, we will use the term ‘economic data’ more broadly than the term HEOR.

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MDR Update: EPSCO Proposes Transition Improvements and EU Commission Issues MDCG 2022-18

At the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) meeting on 9 December 2022, EU Member States unanimously agreed that actions should be taken to ensure that the supply of medical devices is maintained during the Medical Device Regulation (MDR) transition period. Specific issues regarding Notified Body capacity and ongoing expiration of the EU’s Medical Device Directive (MDD) certificates during transition were the main concerns.

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EU Commission Publishes MDR Implementing Regulation for Devices without Medical Purpose (Annex XVI)

In an important step forward for EU manufacturers of devices without a medical purpose, the final version of the ‘Implementing Regulation’ containing the common specifications related to the Medical Device Regulation (MDR) have been adopted.

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