Medical Device Regulation: FDA-CDRH Manufacturing, Policies and Regulation Handbook - Image 1

£131.79

Academic Press Medical Device Regulation: FDA-CDRH Manufacturing, Policies and Regulation Handbook

Name: Medical Device Regulation: FDA-CDRH Manufacturing, Policies and Regulation Handbook
Brand: Academic Press
Price: 131.49 GBP
Availability: InStock

Law

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Description

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

Product Specifications

Brand: Academic Press
Format: Paperback
ASIN: 0323953549
Category: Books > Subjects > Business, Finance & Law > Law
Domain: Amazon UK
Release Date: 24 February 2023
Listed Since: 23 May 2022

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Academic Press Medical Device Regulation: FDA-CDRH Manufacturing, Policies and Regulation Handbook

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