North American Science Association

Medical Laboratory in Irvine, CA
Medical Laboratory in Irvine, CA For over forty years, NAMSA has been the world's leading medical device contract research organization specializing in the safety evaluation of medical devices (class I, II and III) device and packaging materials and drug/device combination products. We assist our customers bring safe, effective and compliant medical products to global markets. We're passionate about our people, our scientific integrity and the breadth of solutions we provide our customers globally.

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9 Morgan
Irvine, CA
92618
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North American Science Association
read moreDriven by our global regulatory expertise and in-depth therapeutic knowledge, NAMSA offers only the most proven solutions to move your medical device through the development lifecycle as efficiently and cost-effectively as possible. Offering product development strategy; medical device testing; regulatory, reimbursement and quality consulting; and clinical research services, we are dedicated to helping you achieve accelerated, successful development and commercialization outcomes. Gain 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.
About Us
read morePassionately driven by our regulatory expertise and in-depth therapeutic knowledge, NAMSA has helped global medical device Sponsors improve healthcare around the world since 1967. Serving as the industry's only 100% medical device-focused, full continuum Contract Research Organization (CRO), our team of more than 1,000 global Associates proudly delivers only the most vetted, proven solutions to provide clients significant resource savings over industry averages. Our suite of solutions includes medical device testing; regulatory, reimbursement and quality consulting; and clinical research services for both medical device and In Vitro Diagnostic (IVD) Sponsors.
Services
read moreFrom concept to post-market, NAMSA's Product Development Strategy (PDS) service offering provides proven solutions to assist clients with any development challenge, therapeutic area, reimbursement issue or regulatory environment. NAMSA is the pioneer of the medical device testing industry and continues to serve as the global marketplace leader for reliable, proven testing services. NAMSA is the industry leader in driving successful regulatory submissions and outcomes through effective, daily interactions with the U.S. FDA, Japan's PMDA, Europe's EMA, and China's NMPA, as well as other international Notified Bodies.
Medical Writing
read moreNAMSA provides a wide range of specialized report writing, manuscript submission and evidence communication services. Our world-class medical writing team is experts at identifying, organizing, interpreting and presenting clinical data in an accurate and professional manner that is highly recognized and trusted by medical device manufacturers and global regulatory entities. The team is also experienced and skilled in defining and prioritizing which reports are required to comply with the Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), MEDDEV 2.7.1 rev.
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