e.alvarado2022-07-05T13:38:23+00:00June 15th, 2022|Categories: Meditrial|Tags: Clinical Trial, Medical Devices, OBSERVATIONAL STUDIES, REAL WORLD EVIDENCE, RWE|
Dr. Paola Antonini, Meditrial scientific director. If well designed, observational studies and registries produce treatment effect data comparable in importance to those in randomized controlled trials,[1] generating information missing in traditional interventional studies and real-world data to support marketing [...]
adminMTE_04792024-02-29T16:54:30+00:00March 19th, 2021|Categories: Clinical Trial, USA|Tags: Clinical Trial, Digital Health, FDA, RWE, USA|
The FDA issued a document reporting examples of real world evidence (RWE) application to support marketing applications for medical devices. The document includes examples of RWE in several submission types: premarket notification 510(k) , De Novo, humanitarian device exemption [...]
Become part of Meditrial! Subscribe to our newsletter.
Meditrial Europe - VAT CHE-115.033.718 © 2009 - 2024 | All Rights Reserved | Privacy | Terms of Use | Advertising Policy
