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Chiavi della conformità medica

Chiavi della conformità medica

CHERIF GHEBACHE

93,68 €
IVA incluido
Disponible
Editorial:
KS OmniScriptum Publishing
Año de edición:
2025
Materia
Tecnología: cuestiones generales
ISBN:
9786209445743
93,68 €
IVA incluido
Disponible

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Sobre IBD

Sommario - Volume ILe chiavi della conformità medica: dall’idea al lancio sul mercato globale è una guida concisa e accessibile per capire come un’innovazione medica diventa un dispositivo sicuro, ad alte prestazioni e conforme ai requisiti internazionali.Il libro presenta gli standard principali - ISO 13485, ISO 14971, ISO 10993, GMP, MDR/IVDR, FDA, IEC 60601, ISO/ASTM 52900 - e spiega il loro ruolo nella qualità, nella gestione del rischio, nella biocompatibilità, nella produzione additiva, nella sicurezza informatica e nella tracciabilità.Utilizzando esempi concreti (impianti, strumenti chirurgici, software medicali, camere bianche, scanner), traccia le fasi essenziali della conformità: progettazione, validazione, test, controllo qualità, gestione dei documenti e certificazione.Il libro evidenzia anche il contributo dell’intelligenza artificiale al monitoraggio normativo, alla garanzia di qualità e alla sicurezza informatica.Attraverso le sue pubblicazioni, l’autore offre un supporto pratico a studenti, ricercatori e industriali e ispira una nuova generazione a vedere la conformità non come un vincolo, ma come una vera e propria leva per l’innovazione, la sicurezza e la competitività globale.

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