Our Associates, Clients and Partners are at the heart of everything we do. We remain committed to providing critical medical device development services while also protecting our communities throughout the COVID-19 Pandemic.
We invite you to access any of the below complimentary resources to learn more about strategies and best practices that can assist Sponsors to proactively address COVID-19 throughout their medical device development and commercialization programs. Additionally, NAMSA’s statement on COVID-19 and its impact to business operations can be found here.
COMING SOON! May 13, 2020 (11 AM – 12 PM ET): How to Manage Clinical Study Data During the COVID-19 Pandemic (Register Here!)
The COVID-19 Pandemic – Proper Clinical Study Management & Protecting Data Validity
(Release Date: April 1)
COVID-19: Biocompatibility of Ventilators and Respiratory Devices
(Release Date: April 7)
European Commission Mandate for EU Parliament Negotiations on MDR Delay: Clarification Regarding Article 120 Section 3 (Release Date: April 9)
EU Response to COVID-19 Pandemic: Proposal to Delay Date of MDR Application to May 2021 for Certain Provisions (Release Date: April 3)
Diagnostic Developers Look to EUA Submission to Combat COVID-19 (Release Date: Feb. 12)
NAMSA, as the industry leader in IVD regulatory knowledge and product development, is proud to have partnered with several domestic and overseas IVD Sponsors for Emergency Use Authorization (EUA) assay submissions to combat COVID-19. IVD Sponsors seeking expedited EUA development of Serology and Molecular assays, are encouraged to reach out to us to learn more. Let us help you in delivering much-needed COVID-19 diagnostics to advance patient healthcare around the globe. Contact us here.
In a recent survey of over 500 clients, NAMSA gathered information to better understand the impact of COVID-19 on medical device Sponsors’ product development efforts. While the majority of device makers throughout the U.S., APAC and EMEA have been at least moderately affected by the pandemic, the most significant area of impact exists within the clinical trial space. Final results are below.
