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July 2020

Transitioning from EUA to 510(k) Clearance for IVD Products, What to Expect, a NAMSA webinar

July 16 @ 11:00 am - 12:00 pm
Online Event OH United States

In Vitro Diagnostic (IVD) products go through a stringent 510(k) evaluation process in order to be certified and placed in the U.S. However, as a result of the ongoing COVID-19 Pandemic, several assays and analyzers have entered the market through the Emergency Use Authorization (EUA) pathway to fast track approval. While EUA provides an opportunity for IVD manufacturers, these IVDs will eventually have to comply with U.S. FDA 510(k) requirements to remain on the market. Join BioOhio member NAMSA for…

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NAMSA & RAPS present Achieving Medical Device Development Success Through Early Implementation of Regulatory, Reimbursement and Clinical Research Strategies

July 29 @ 10:00 am - 11:00 am
Online Event OH United States

Regulatory affairs professionals must have both a solid foundation surrounding regulatory strategy and an in-depth understanding of how this plan links to the overall product development strategy to achieve efficient, cost-effective development outcomes, and commercialization success. Whether navigating a new regulatory pathway, understanding how to secure clinical data to achieve successful commercial outcomes or ensuring reimbursement strategies are coordinated with regulatory strategy throughout the planning process, it is essential all stakeholders to take steps to secure broader market success for…

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