Practical design control implementation for medical devices [electronic resource] /
Jose M. Justiniano, Venky Gopalaswamy
- Boca Raton : Interpharm/CRC, c2003
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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
1574911279
2002-013391
Medical instruments and apparatus--Design and construction Medical instruments and apparatus--Quality control Equipment design Equipment and Supplies--standards Quality control