Practical design control implementation for medical devices /
Justiniano, Jose M.
Practical design control implementation for medical devices / Jose M. Justiniano, Venky Gopalaswamy - Boca Raton : Interpharm/CRC, 2003 - v, 223 p. : ill. ; 26 cm.
References : p. 203 - 206
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 (alk. paper) RM1012.84
2002-013391
Equipment design
Equipment and Supplies--standards.
Quality control
W26
Practical design control implementation for medical devices / Jose M. Justiniano, Venky Gopalaswamy - Boca Raton : Interpharm/CRC, 2003 - v, 223 p. : ill. ; 26 cm.
References : p. 203 - 206
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 (alk. paper) RM1012.84
2002-013391
Equipment design
Equipment and Supplies--standards.
Quality control
W26