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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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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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NAMSA ACQUIRES UK-BASED PERFECTUS BIOMED GROUP TO ENHANCE CUSTOMIZED MICROBIOLOGICAL SOLUTIONS

NAMSA, a world-leading MedTech Contract Research Organization (CRO) offering global end-to-end development services, announced today its acquisition of Perfectus Biomed Group, a UK-based laboratory providing customized microbiological services.

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FDA Releases Long-Awaited Final Guidance for Clinical Decision Support Software

On the heels of the September 26 release of the FDA's, “Digital Health Software Precertification (Pre-Cert) Pilot Program: Tailored Total Product Lifecycle Approaches and Key Findings,” the regulatory authority has released the long-awaited final guidance for “Clinical Decision Support Software” (September 28, 2022). This final guidance replaces the 2017 and 2019 draft guidance documents.

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Digital Health Software Pre-Certification Update: Final FDA Report Revealed

On September 26, 2022, the FDA a final report entitled, “Digital Health Software Precertification (Pre-Cert) Pilot Program: Tailored Total Product Lifecycle Approaches and Key Findings.” The Pre-Cert Program is intended to fast-track digital health products by reducing regulatory hurdles for developers of Software as a Medical Device (SaMD).

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Monkeypox: Not all EUAs Are Created Equal

The FDA declared a public health emergency for monkeypox on August 4, 2022 and authorized EUAs for diagnostic tests as of September 7, 2022. For this latest policy, the FDA is inviting experienced test developers with high manufacturing capacity to notify the FDA of their intent to submit an EUA request by October 13, 2022.

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First Manual on Borderline and Classification under MDR Published by the European Commission

On the 7 September 2022, the European Commission announced publication of the latest manual on borderline and classification in the community regulatory framework for medical devices and In Vitro Diagnostic medical devices (Borderline Manual). This is the first version of the manual published under the requirements of the EU MDR.

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