Practical design control implementation for medical devices /
[Book]
Jose M. Justiniano, Venky Gopalaswamy
Boca Raton :
Interpharm/CRC,
c2003
v, 223 p. :
ill. ;
26 cm
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
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Medical instruments and apparatus-- Design and construction
Medical instruments and apparatus-- Quality control