Author | Justiniano, Jose M |
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Title | Practical design control implementation for medical devices [electronic resource] / Jose M. Justiniano, Venky Gopalaswamy |
Imprint | Boca Raton : Interpharm/CRC, c2003 |
Connect to | http://marc.crcnetbase.com/isbn/9780203010716 |
Descript | v, 223 p. : ill |
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