NAMSA delivers high-quality, competitive, on-time medical device development services. To successfully and consistently deliver outstanding outcomes for clients, we adhere to various global requirements and certifications.
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Access our latest White Papers, Guides and Webinars, presented by the medical device industry’s foremost thought leaders. Or, join us for an in-person event to learn proven strategies and best practices direct from the experts.
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 what recent news means for your medical device development plans and commercial operations.
Our podcast and video series are focused on providing critical information gained throughout NAMSA’s 55+ year history of effectively managing innovative development programs for global medical device and IVD manufacturers. Access to learn more about best practices, proven strategies and resources critical to successful market introduction and commercialization.
NAMSA Test Navigator
NAMSA’s Test Navigator highlights the most commonly used tests within the medical device industry and also provides thousands of unique testing services for special test and study requirements.
E-Learning: a convenient, easy way to gain in-depth knowledge regarding relevant, timely medical device development topics.
EU MDR & IVDR Planning Resources
Increased regulatory oversight, new clinical evidence requirements and intensified supervision of Notified Bodies are just some of the new requirements of the EU MDR & IVDR. Our regulatory experts can help you master the road to EU regulatory compliance.
While the EUA pathway is still available, the window for pursuing a EUA is slowly shrinking and being replaced with full U.S. Food and Drug Administration (FDA) approval to remain on market. With clinical studies requiring six to 18 months to complete, it is imperative that IVD manufacturers are proactive to identify gaps, prepare pre-submissions and execute clinical studies.