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Development of FDA-Regulated Medical Products: Prescription Drugs, Biologics, and Medical Devices (Hardcover)
by Elaine Whitmore
This book is intended for anyone involved in pharmaceuticals, biologics, or medical devices. Helpful references include a glossary, acronyms, and a list of useful resources.
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Mastering and Managing the FDA Maze: Medical Device Overview: A Training and Management Desk Reference for Manufacturers Regulated by the Food and Drug Administration by Gordon Harnack
This book will help you understand the regulations and be prepared for the FDA investigator.
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The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices (Hardcover)
by Kimberly A. Trautman
Compares the FDA Regulations and quality standard requirements.
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Design Controls for the Medical Device Industry (Hardcover)
by Marie B. Teixeira
The guide to implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations.
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ISO 13485:2003 & FDA QSR (21 CFR 820) Quality Manual, 34 Procedures and Forms (CD-ROM)
by Jack Kanholm
Template documentation on CD-ROM includes a quality manual, operational procedures, and forms. The documentation complies with both the international and US FDA regulations.
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ISO 13485 (EN 46000) In Our Company, Self-Study Course for Personnel (Paperback)
by Jack Kanholm
The workbook is intended for training personnel in companies that either operate an ISO 13485 quality system or are implementing it and preparing for certification.
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The Regulatory Compliance Almanac (Hardcover)
by Les Schnoll
A comprehensive guide to the regulations governing good manufacturing, clinical, and laboratory practices from the FDA, EPA, and the European Union.
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Maintenance Management & Regulatory Compliance Strategies (Hardcover)
by Terry Wireman
A reference for implementing an effective maintenance management strategy to support the regulatory requirements..
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