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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: 9786209367519
  • Binding: Paperback
  • Subject: N/A
  • Publisher: Editions Universitaires Europeennes
  • Publisher Imprint: Editions Universitaires Europeennes
  • Publication Date:
  • Pages: 128
  • Original Price: GBP 52.98
  • Language: French
  • Edition: N/A
  • Item Weight: 182 grams
  • BISAC Subject(s): General

R�sum� - Tome ICl�s de la conformit� m�dicale: de l'id�e � la mise sur le march� mondial est un guide synth�tique et accessible pour comprendre comment une innovation m�dicale devient un dispositif s�r, performant et conforme aux exigences internationales.L'ouvrage pr�sente les normes cl�s - ISO 13485, ISO 14971, ISO 10993, GMP, MDR/IVDR, FDA, IEC 60601, ISO/ASTM 52900 - et explique leur r�le dans la qualit�, la gestion des risques, la biocompatibilit�, la fabrication additive, la cybers�curit� et la tra�abilit�.� travers des exemples concrets (implants, instruments chirurgicaux, logiciels m�dicaux, salles propres, scanners), il retrace les �tapes essentielles de la conformit� conception, validation, essais, contr�le qualit�, gestion documentaire et certification.Le livre met �galement en lumi�re l'apport de l'intelligence artificielle dans la veille r�glementaire, l'assurance qualit� et la cybers�curit�.Par ses publications, l'auteur offre un appui concret aux �tudiants, chercheurs et industriels, et inspire une nouvelle g�n�ration � percevoir la conformit� non comme une contrainte, mais comme un v�ritable levier d'innovation, de s�curit� et de comp�titivit� mondiale.

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