Practical design control implementation for medical devices - Justiniano, Jose M.; Gopalaswamy, Venky (Boca Raton : Interpharm/CRC, 2003)
Motivation for design control and validation -- Design control requirements -- Design transfer and process validation -- Quality system for design control -- Measuring design control program effectiveness -- Medical device reliability overview -- Reliability plan -- Risk analysis and FMEA -- Designing-in reliability -- Reliability and design verification -- Reliability and design validation
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Includes bibliographical references and index
Keywords: Medical instruments and apparatus -- Design and construction; Medical instruments and apparatus -- Quality control; Equipment design; Equipment and Supplies -- standards; Quality control