Practical design control implementation for medical devices [electronic resource] / Jose M. Justiniano, Venky Gopalaswamy

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Includes bibliographical references and index

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