Today, NESTcc announced its first Real-World Evidence Test-Cases. Initially submitted through a public call for concepts in January 2018, these Test-Cases will answer questions of importance to the medical device ecosystem through collaborations between NESTcc Network Collaborators and participating industry partners. The eight projects include both 510(k) and premarket approval regulatory pathways, and address devices across five disease areas. Read the full press release, including an overview of the projects and the industry partners, here.
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For #TestCaseTuesday, check out our case study for a project that evaluated data relevance and reliability to assess if real-world data would be “fit for purpose” for regulatory submission supporting a potential study for label expansion. Download: hubs.ly/Q018VCNy0 pic.twitter.com/T9Gu4uM8uS 3 months ago