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

Description

Book Synopsis: 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.

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Details

Are you a medical device manufacturer looking to navigate the complex world of FDA-CDRH regulations? Look no further! Our Medical Device Regulation: FDA-CDRH Manufacturing, Policies and Regulation Handbook is the ultimate reference tool to help you understand and meet the regulatory requirements. From criteria for medical devices to marketing rules and testing standards, this comprehensive book has got you covered.

Gain insights into the FDA-CDRH thinking on medical device regulation with our expertly curated content. Whether you are based in the United States or internationally, this book provides invaluable information for premarket application and compliance.

Take advantage of the unique focus of this handbook, specially tailored for regulatory affairs professionals and those seeking certification. With real-life case studies and practical applications of regulations, you'll be able to apply your knowledge to real-world scenarios.

Don't miss out on this opportunity to enhance your understanding of medical device regulation. Stay ahead of the competition and ensure compliance with our comprehensive handbook. Order your copy today and pave the way for success in the highly regulated world of medical devices.

Order now to gain an essential advantage in the medical device industry!

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