Guidelines for failure mode and effects analysis for medical devices /

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 - Se...

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Detalles Bibliográficos
Autor Corporativo: DYADEM
Formato: Libro
Lenguaje:Inglés
Publicado: Boca Ratón : DYADEM, 2003.
Materias:
DISPOSITIVOS MEDICOS
MODOS DE FALLA
ANALISIS DE EFECTOS
CONTROL DE CALIDAD
SEGURIDAD
Aporte de:Registro referencial: Solicitar el recurso aquí
Bibliotecas (ING-UNLP) de Universidad Nacional de La Plata
Descripción
Sumario: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).
Descripción Física:paginación variada : il.
ISBN:0849319102

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