Edición en Inglés
|
dashboard
Serie
Mastering the FDA Approval Process
|
"Navigating the FDA 510(k) Process: A Comprehensive Guide to Premarket Success" is an essential resource for medical device manufacturers and innovators looking to bring their products to market in the U.S. This guide provides a step-by-step roadmap through the FDA's 510(k) premarket notification process, offering detailed insights into device classification, substantial equivalence, testing requirements, and submission strategies. It covers everything from preparing a strong application to avoiding common pitfalls, navigating third-party reviews, and ensuring post-market compliance. With real-world case studies and expert tips, this book equips readers with the knowledge and tools to achieve successful 510(k) clearance and ensure regulatory success.
Título : Navigating the FDA 510(k) Process
EAN : 9798227884510
Editorial : DrMedHealth
El libro electrónico Navigating the FDA 510(k) Process está en formato ePub protegido por CARE
¿Quieres leer en un eReader de otra marca? Sigue nuestra guía.
Conectarme
Mi cuenta