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Having a robust and functional Quality Management system is a QSR requirement for all Pharmaceutical,Biomedical,and Medical Device companies.This book does the
Designing a World-Class Quality Management System for FDA Regulated Industries
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This is an autobiographical treatise of an American citizen raised during a period our nation was placed on trial in the battle for the civil right of racial eq
Medical Device Guidelines and Regulations Handbook
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This comprehensive resource features in-depth discussions of important guidelines and regulations needed to understand and properly meet medical device code-rel
Quality Risk Management in the FDA-Regulated Industry
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The purpose of this new edition is to offer an updated view of the risk management field as it applies to medical products. Since the publication of the first e
Six Sigma for Medical Device Design
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Six Sigma for Medical Device Design is the first book to apply Six Sigma principles to the design of medical devices. Authored by experienced professionals, it