000 01460cam a22003134a 4500
005 20250914130821.0
008 030813s2003 xxua 001 0 eng b
010 _a2002-013391
020 _a1574911279 (alk. paper)
_cRM1012.84
039 9 _a200311120835
_blailawati
_c200310131439
_dzainol
_c200308131201
_dfaizah
_y08-07-2003
_zrazalis
060 _aW26
090 _aW26.J96p 2002
100 1 _aJustiniano, Jose M.
245 1 0 _aPractical design control implementation for medical devices /
_cJose M. Justiniano, Venky Gopalaswamy
260 _aBoca Raton :
_bInterpharm/CRC,
_c2003
300 _av, 223 p. :
_bill. ;
_c26 cm.
504 _aReferences : p. 203 - 206
505 0 _aMotivation 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
650 2 _aEquipment design
650 2 _aEquipment and Supplies
_xstandards.
650 2 _aQuality control
700 1 _aGopalaswamy, Venky
907 _a.b1323738x
_b2019-11-12
_c2019-11-12
942 _c01
_n0
_kW26.J96p 2002
914 _avtls000338049
991 _aJabatan Fisiologi
998 _ad
_b2003-07-08
_cm
_da
_feng
_gxxu
_y0
_z.b1323738x
999 _c323266
_d323266