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Elsevier Regulatory Affairs for Biomaterials and Medical Devices

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Description

Navigating the complex landscape of medical device compliance is essential for successful product clearance. This book from the Woodhead Publishing Series in Biomaterials provides a comprehensive guide to the regulatory practices and policies required for biomaterials and medical devices. It examines the specific systems used in the USA and across the rest of the world to help readers understand global requirements. The text covers essential procedures such as commercialization, clinical development, and general good practice manufacturing. It also provides information on post market surveillance to ensure ongoing compliance. This resource is especially useful for smaller companies that need clear guidance on managing regulatory issues and international standards in the medical device industry.

Key Features

Part of the Woodhead Publishing Series in Biomaterials for specialized technical knowledge.

Covers global regulations and regulatory issues surrounding biomaterials and medical devices.

Provides detailed information on regulatory systems in the USA and international markets.

Includes essential topics such as commercialization and clinical development procedures.

Addresses general good practice manufacturing and post market surveillance requirements.

Offers a helpful resource for smaller companies managing regulatory compliance.

Product Specifications

Format
hardcover
Domain
Amazon UK
Release Date
14 October 2014
Listed Since
18 July 2013

Barcode

No barcode data available

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