Guidelines for failure mode and effects analysis for medical devices /
DYADEM.
- Boca Ratón : DYADEM, 2003.
- paginación variada : il.
Introduction - Regulations and standards governing medical device manufacturing - Risk analysis methodologies - Overview of FMEA - FMEA procedures - FMEA team - Pitfalls with FMEA - Common tools used with FMEA - Product life cycle and FMEA - Product/design FMEA - Process FMEA - Application FMEA - Service FMEA - Post FMEA study - Control plans - Overview of failure mode, effects and criticality analysis (FMCA).
0849319102
DISPOSITIVOS MEDICOS MODOS DE FALLA ANALISIS DE EFECTOS CONTROL DE CALIDAD SEGURIDAD