Can I read Medical Device Regulation : FDA-CDRH Manufacturing, Policies and Regulation Handbook on EtoBox?

Medical Device Regulation : FDA-CDRH Manufacturing, Policies and Regulation Handbook by Elijah Wreh is a nonfiction available to read on EtoBox.

What is Medical Device Regulation : FDA-CDRH Manufacturing, Policies and Regulation Handbook about?

Medical Device Regulation provides the current FDA-CDRH thinking on the regulation of medical devices. This book offers information on how devices meet criteria for being a medical device, which agencies regulate medical devices, how policies regarding regulation affect the market, rules regarding marketing, and laws and standards that govern testing. This practical, well-structured reference tool helps medical device manufacturers both in and out of the United States with premarket application and meeting complex FDA regulatory requirements. The book delivers a comprehensive overview of the field from an author with expertise in regulatory affairs and commercialization of medical devices. Offers a unique focus on the regulatory affairs industry, specifically targeted at regulatory affairs professionals and those seeking certification Puts regulations in the context of contemporary design Includes case studies and applications of regulations

Who reads Medical Device Regulation : FDA-CDRH Manufacturing, Policies and Regulation Handbook?

Author

Elijah Wreh

Publisher

ELSEVIER ACADEMIC PRESS

Published

2023

Language

EN

ISBN

9780323953535

Category

nonfiction

Subjects

Engineering, Stem