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NAMSA

NAMSA IS THE WORLD’S LEADING MEDTECH CRO OFFERING GLOBAL 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 VS. 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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Best Practices for MDR-Compliant Clinical Evaluations

Learn how to align clinical evaluations with MDR in our guide, featuring NAMSA's expert insights and auditor feedback for medical device manufacturers.

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Navigating the New MDCG Guidance Documents on CIP and IB

Discover key insights on the latest MDCG guidance for EU medical device clinical investigations, aiding in compliant CIP and IB development.

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Understanding the ISO 18562:2024 Standards Update for Medical Devices

The updated ISO 18562 standards, released in March 2024, now cover medical respiratory PPE like surgical masks and introduce new terms that could change testing requirements for medical devices. They emphasize the importance of considering a device's aging and life cycle, as well as providing detailed breathing volumes for expanded patient populations. These changes aim to enhance safety evaluations for devices throughout their use, presenting manufacturers with new challenges.

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Collection of Race and Ethnicity Data in Clinical Studies – Standardizing the Sociocultural Construct of Our Society

The FDA's updated guidance on race and ethnicity data collection in clinical trials calls for using OMB-standardized categories to ensure accurate demographic representation. Sponsors must create a Diversity Action Plan, with mandatory implementation for new studies within 180 days after final guidance. Participants will self-report race and ethnicity, with the option to identify as multiracial and confirm their information against medical records.

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Medical Device Software: Considerations for Device and Risk Characterization

On February 2, 2024, the IMDRF released a draft guidance for public comment on Software as a Medical Device (SaMD). This document aims to unify global regulations by detailing device characterization and risk assessment for medical software. It seeks to create a shared understanding that can navigate the varied regulatory landscapes, promoting safer digital health solutions. Public feedback is encouraged to refine these critical guidelines.

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