TY  - BOOK
AU  - Justiniano,Jose M.
AU  - Gopalaswamy,Venky
TI  - Practical design control implementation for medical devices
SN  - 1574911279 (alk. paper)
PY  - 2003///
CY  - Boca Raton
PB  - Interpharm/CRC
KW  - Equipment design
KW  - Equipment and Supplies
KW  - standards
KW  - Quality control
N1  - 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
ER  -