TY - BOOK AU - Kuwahara,Steven S. TI - Quality systems and GMP regulations for device manufacturers: a practical guide to U.S., European, and ISO requirements SN - 087389426X (alk. paper) PY - 1998/// CY - Milwaukee, Wis., Buffalo Grove, Ill. PB - ASQ Quality Press, Interpharm Press KW - Medical instruments and apparatus KW - Standards KW - United States KW - Europe KW - Medical instruments and apparatus industry KW - Law and legislation KW - Current Good manufacturing practices (CGMP) N1 - Includes bibliographical references (p. 213-215) and index ER -