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

CONTENT

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


SUBJECT

  1. Medical instruments and apparatus -- Design and construction
  2. Medical instruments and apparatus -- Quality control
  3. Electronic books.