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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 Product Development Strategy Medical Device Testing Clinical Research RegulatoryQuality Reimbursement IVD NAMSA APEX Program™ Therapeutic Expertise White Papers EventsWebinars Test Navigator 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 May 10, 2024 A Product Development Plan For My Laboratory Developed Test Discover key strategies for LDTs facing FDA regulation changes in our latest blog on product development planning. Read More May 08, 2024 Navigating Medical Device Clinical Trial Site Selection: A Data-Driven Approach Learn how to align clinical evaluations with MDR in our guide, featuring NAMSA's expert insights and auditor feedback for medical device manufacturers. Read More May 02, 2024 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. Read More May 01, 2024 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. Read More April 17, 2024 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. Read More HAVE QUESTIONS? Let NAMSA’s medical device development experts guide you in the right direction. Visit FAQ Contact Us Subscribe to NAMSA Events Newsletter Sign Up Subscribe to NAMSA Events Newsletter First Name Last Name Email Company Job Title (Optional) By submitting this form, you are providing NAMSA consent to contact you directly regarding NAMSA’s services. The information you are providing will be processed and stored by NAMSA to better understand your product needs and interests. At any time, you can submit a request to withdraw your consent for the use of information provided by you by emailing communications@namsa.com . 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