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Clés de la conformité médicale by Cherif Ghebache

Clés de la conformité médicale

by Cherif Ghebache
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Book cover type: Paperback
  • ISBN13: 9786209443183
  • Binding: Paperback
  • Subject: N/A
  • Publisher: Editions Notre Savoir
  • Publisher Imprint: Editions Notre Savoir
  • Publication Date:
  • Pages: 108
  • Original Price: GBP 52.98
  • Language: Spanish
  • Edition: N/A
  • Item Weight: 155 grams
  • BISAC Subject(s): General

Resumen - Volumen IClaves de la conformidad m�dica: de la idea al lanzamiento al mercado mundial es una gu�a concisa y accesible para entender c�mo una innovaci�n m�dica se convierte en un dispositivo seguro y de alto rendimiento que cumple los requisitos internacionales.El libro presenta las normas clave -ISO 13485, ISO 14971, ISO 10993, GMP, MDR/IVDR, FDA, IEC 60601, ISO/ASTM 52900- y explica su papel en la calidad, la gesti�n de riesgos, la biocompatibilidad, la fabricaci�n aditiva, la ciberseguridad y la trazabilidad.A partir de ejemplos concretos (implantes, instrumentos quir�rgicos, software m�dico, salas blancas, esc�neres), traza las etapas esenciales de la conformidad: dise�o, validaci�n, pruebas, control de calidad, gesti�n de documentos y certificaci�n.El libro tambi�n destaca la contribuci�n de la inteligencia artificial al control normativo, la garant�a de calidad y la ciberseguridad.A trav�s de sus publicaciones, el autor ofrece apoyo pr�ctico a estudiantes, investigadores e industriales, e inspira a una nueva generaci�n para que vea la conformidad no como una limitaci�n, sino como una aut�ntica palanca para la innovaci�n, la seguridad y la competitividad mundial.

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