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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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ASCA Accreditation: FDA Annual Report and NAMSA Customer Experience

When it comes to medical device development, regulatory compliance is essential. In the United States, the Food and Drug Administration (FDA) is responsible for regulating medical devices and, specifically, their Accreditation Scheme for Conformity Assessment (ASCA Program) provides accreditation to laboratories that assess medical devices for compliance with regulatory requirements.

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Your Guide to Biostatistics Outsourcing and Consulting

On March 30, 2023, the U.S. FDA issued draft guidance outlining the use of Predetermined Change Control Plans (PCCPs) for AI/ML software.

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Just Released: Updated Transitional Arrangements for UKCA Process

On 28 April 2023, the Medicines and Healthcare Products Regulatory Agency (MHRA) published a communication updating previous information on the extension period for the mandatory implementation of the United Kingdom Conformity Assessment (UKCA) process for medical devices. This update is resultant from the recent amendment by the EU Commission (EU 2023/607) to extend the transition period for MDR 2017/745.

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The New England Journal of Medicine: Transcatheter Arterialization of Deep Veins in Chronic Limb-Threatening Ischemia

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AI Guidance for Medical Devices | NAMSA

On March 30, 2023, the U.S. FDA issued draft guidance outlining the use of Predetermined Change Control Plans (PCCPs) for AI/ML software.

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