Quality systems and GMP regulations for device manufacturers : a practical guide to U.S., European, and ISO requirements - Kuwahara, Steven S. (Milwaukee, Wis. : ASQ Quality Press ; Buffalo Grove, Ill. : Interpharm Press, 1998)
Includes bibliographical references (p. 213-215) and index
Keywords: Medical instruments and apparatus -- Standards -- United States; Medical instruments and apparatus -- Standards -- Europe; Medical instruments and apparatus industry -- Law and legislation -- United States; Current Good manufacturing practices (CGMP)