Go to Client Portal
NAMSA

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

Contact Us Today

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

Contact Us Today

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

Contact Us Today

HELPING MEDICAL DEVICE SPONSORS IMPROVE HEALTHCARE SINCE 1967

Contact Us Today

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.

Learn More

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.

Browse All Resources

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.

Access Now

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.

Read More

Industry Update: Quality Management System Regulation (QMSR)

Explore FDA's new QMSR aligning with ISO 13485, simplifying compliance for device makers. Get ready with NAMSA's expert transition guidance.

Read More

Three Essentials for a Good Clinical Study Report

Learn the key elements of a compelling CSR for medical device success with NAMSA's expert guidance.

Read More

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.

Read More

MDR Vigilance: New MDCG Guidance Published

This blog covers the EU Commission's newly published MDCG Guidance documents relating to medical device and in vitro diagnostic medical device vigilance.

Read More

HAVE QUESTIONS?

Let NAMSA’s medical device development experts guide you in the right direction.