— IVD — UNIQUELY IVD: BUILT FOR THE UNIQUE NEEDS OF IVD SPONSORS LET OUR DEDICATED IN VITRO DIAGNOSTICS TEAM TAKE THE GUESSWORK OUT IVD DEVELOPMENT AND REGULATORY COMPLIANCE. CONTACT US 0 IVD STUDIES SUPPORTED 0 GLOBAL REGULATORY SUBMISSIONS 0 IVD TRIAL SITES MANAGED 0 MONTHLY IVDR TECH FILE ASSESSMENTS EU IVDR COMPLIANCE COUNTDOWN IVDR 6 Months 2 Days 21 Hours LEARN MORE OVERVIEW NAMSA’s stand-alone IVD business unit, the only within the Contract Research Organization (CRO) industry, is focused on meeting the unique product development needs of IVD manufacturers. We help clients fast-track the commercialization of life-changing IVD products through our proactive approach and in-depth knowledge of IVD requirements. We not only understand how to accurately interpret the complicated regulatory challenges that IVD manufacturers sometimes face, but we also help you simplify the development and implementation of effective development strategies. Whether supporting IVD regulatory assessments and submissions, developing IVDR compliant technical files, designing and managing clinical trials or building ISO 13485:2016 and 21 CFR part 820 compliant quality systems… we’ve got you covered. Our IVD experts partner with your team on a global scale and in a variety of capacities. Some clients choose to outsource all regulatory, quality, reimbursement and clinical research initiatives, while others collaborate with us on portions of their IVD regulatory or clinical study processes. No matter your needs, NAMSA is the most flexible IVD CRO in the industry and we pride ourselves on delivering high-quality results by leveraging our collective global expertise. We partner with you every step of the way to ensure your success. IVD Clinical Research, Biostatistics & Data Management Services IVD Regulatory Services IVD Reimbursement Support Services IVD Quality Systems Services IVD Therapeutic Expertise IVD Client Testimonials RESOURCES WHITE PAPER EUDAMED Actor Registration Module: A Step Towards Greater Medical Device And IVD Product Safety And Transparency LEARN MORE GUIDE NAMSA Guide: The Design Of Clinical Trials For CLIA-Waived Point-Of-Care Tests LEARN MORE LITERATURE NAMSA Start-Up 360: Accelerating IVD Product Development LEARN MORE WHITE PAPER Navigating Clinical Trials In The Era Of COVID-19: An Assessment Of Short-Term And Long-Term Strategies LEARN MORE WEBINAR Transitioning From EUA To 510(K) Clearance For IVD Products: What To Expect LEARN MORE WEBINAR IVD Clinical Trials: Effective Site Selection Techniques – A Site And CRO Perspective LEARN MORE GUIDE NAMSA Guide: How To Design & Develop EDC Systems For Optimal IVD Clinical Trial Management LEARN MORE WEBINAR Optimizing Electronic Data Capture (EDC) For IVD Clinical Trials LEARN MORE GUIDE NAMSA Guide: In Vitro Diagnostic (IVDR) Readiness Guide LEARN MORE WEBINAR Do’S & Don’Ts For Early-Stage IVD Product Development & Risk Mitigation LEARN MORE SUBSCRIBE TO NAMSA EVENTS NEWSLETTER SIGN UP JOIN THE NAMSA NETWORK Update your profile, post comments on the blog; sign-up for events, webinars and classes; receive email alerts and more. REGISTER Already have an account? Please Login Here NAMSA CLIENT PORTAL Login to the NAMSA Client Portal for sample submissions, testing reports, project tracking, and more. CLIENT PORTAL Careers Accreditations & Certifications Site Map Terms of Use Privacy Statement EU-U.S. & Swiss-U.S Privacy Shield Website Accessibility Statement International Sites: United Kingdom France Germany China Japan CONTACT US +1 866 · 666 · 9455 (toll free) +1 419 · 666 · 9455 (outside of USA) © North American Science Associates, LLC 2021 Website Design, Hosting and Maintenance by MVP Marketing + Design Cookie SettingsAccept all cookies