NAMSA IS THE WORLD’S LEADING MEDTECH CRO OFFERING GLOBAL DEVELOPMENT SERVICES

DRIVEN BY ITS GLOBAL REGULATORY EXPERTISE AND IN-DEPTH THERAPEUTIC KNOWLEDGE

FROM CONCEPT TO POST-MARKET, DELIVERING SIGNIFICANT TIME SAVINGS VS. INDUSTRY AVERAGES

HELPING MEDICAL DEVICE SPONSORS IMPROVE HEALTHCARE SINCE 1967

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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April 10, 2024

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.

April 02, 2024

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On February 2, 2024, the IMDRF released a draft guidance for public comment on Software as a Medical Device (SaMD).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.

March 26, 2024

Revolutionizing Healthcare: The Rise of Medical Device Software and EU Regulatory Compliance

In the rapidly evolving field of healthcare technology, NAMSA provides expert guidance on navigating the complex regulatory landscape for Medical Device Software (MDSW) in Europe. The blog discusses the importance of clinical and performance evaluations according to EU regulations, highlighting the challenges manufacturers face in demonstrating safety and effectiveness. It emphasizes the need for thorough data analysis and risk assessment, particularly in areas like software safety, risk classification, and the lifespan of MDSW. NAMSA's specialized medical writing teams offer their extensive expertise to assist MDSW manufacturers in achieving compliance and fostering innovation within the digital health space.

March 20, 2024

FDA Town Hall Series on Ethylene Oxide Sterilization and Alternative Sterilization Modalities

Explore FDA efforts to reduce EO use in medical device sterilization, the rise of VHP, and how NAMSA can assist with sterilization validation.

March 13, 2024

MDCG 2024-2: Procedures for the Updates of the European Medical Device Nomenclature

Learn about EMDN updates in the new MDCG 2024-2 guidance and its impact on medical device manufacturers.

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