Title:
Practical design control implementation for medical devices
Author:
Justiniano, Jose M.
ISBN:
9780203010716
Publication Information:
Boca Raton : Interpharm/CRC, c2003.
Physical Description:
v, 223 p. : ill.
Contents:
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.
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