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).

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DISPOSITIVOS MEDICOS
MODOS DE FALLA
ANALISIS DE EFECTOS
CONTROL DE CALIDAD
SEGURIDAD

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