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Clés de la conformité médicale
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ISBN10: 6209367518
ISBN13: 9786209367519
Publisher: Editions Universitaires Europeennes
Published: Dec 5 2025
Pages: 128
Weight: 0.40
Height: 0.30 Width: 6.00 Depth: 9.00
Language: French
ISBN13: 9786209367519
Publisher: Editions Universitaires Europeennes
Published: Dec 5 2025
Pages: 128
Weight: 0.40
Height: 0.30 Width: 6.00 Depth: 9.00
Language: French
Résumé - Tome IClés de la conformité médicale: de l'idée à la mise sur le marché mondial est un guide synthétique et accessible pour comprendre comment une innovation médicale devient un dispositif sûr, performant et conforme aux exigences internationales.L'ouvrage présente les normes clés - ISO 13485, ISO 14971, ISO 10993, GMP, MDR/IVDR, FDA, IEC 60601, ISO/ASTM 52900 - et explique leur rôle dans la qualité, la gestion des risques, la biocompatibilité, la fabrication additive, la cybersécurité et la traçabilité.À travers des exemples concrets (implants, instruments chirurgicaux, logiciels médicaux, salles propres, scanners), il retrace les étapes essentielles de la conformité conception, validation, essais, contrôle qualité, gestion documentaire et certification.Le livre met également en lumière l'apport de l'intelligence artificielle dans la veille réglementaire, l'assurance qualité et la cybersécurité.Par ses publications, l'auteur offre un appui concret aux étudiants, chercheurs et industriels, et inspire une nouvelle génération à percevoir la conformité non comme une contrainte, mais comme un véritable levier d'innovation, de sécurité et de compétitivité mondiale.
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