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Austria, l’obbligo vaccinale entra in vigore: quali sono le regole e le sanzioniDEKA tra i primi al mondo certificati MDR per scopi anche non medici di Italpress   11-07-2024 - 12:03 Link copiato #iubenda-cs-banner .iub_ts_bc:not(.iubenda-custom-content) *,investimenti#iubenda-cs-banner [class*=" iub"],#iubenda-cs-banner [class^=iub],.iubenda-tp-btn:not([data-tp-nostyle]){ 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background-color: #fff; border-radius: 0.5rem; box-shadow: 0 12px 24px rgba(0, 0, 0, 0.12); font-family: sans-serif; content: 'Loading...'; display: flex !important; font-size: 13px; font-weight: bold; line-height: 1; justify-content: center; min-height: 50px; text-transform: uppercase;}#speakup-player:empty{ display: block;} MILANO (ITALPRESS) - TÜV SÜD, uno dei principali organismi di certificazione a livello globale, ha rilasciato a DEKA M.E.L.A.,azienda leader italiana nella produzione di dispositivi laser per applicazioni mediche e non mediche, la certificazione MDR (Medical Device Regulation) per i suoi prodotti. "Questa certificazione - spiega una nota - segna un importante traguardo per Deka, essendo certamente tra i primi fabbricanti al mondo (se non addirittura il primo fabbricante a livello globale) di dispositivi medici attivi che ha anche prodotti con intended use non medico a ricevere tale riconoscimento da parte di TÜV SÜD. Di sicuro la società si attesta come la prima in tutto il mondo tra i clienti di TÜV SÜD".Deka è un'azienda internazionale, parte del Gruppo El.En., e realizza dispositivi laser tecnologicamente avanzati sia per uso medico che non. La nuova certificazione MDR, ottenuta secondo l'Allegato XVI che include prodotti senza una destinazione d'uso medica, "testimonia l'impegno di Deka nella fornitura di prodotti di alta qualità e sicurezza - continua la nota -. I dispositivi in oggetto sono stati inclusi nel Reg. EU 745/2017 in quanto sono simili ai dispositivi medici in termini di funzione e profilo di rischio, e quindi devono dimostrare la conformità alle "Common Specifications" (CS). Il processo di certificazione, guidato dal team italiano di TÜV SÜD, ha evidenziato la conformità dei dispositivi Deka Laser alle normative europee più stringenti, confermando l'eccellenza tecnologica e l'innovazione continua che contraddistinguono l'azienda italiana"."Siamo orgogliosi di poter consegnare a Deka Laser questo importante Certificato in accordo ai requisiti dell'allegato XVI del Reg. EU 745/2017 - sottolinea Loris Chiusoli, Business Unit Manager MHS di TÜV Italia -. Questo formale riconoscimento testimonia in maniera indelebile l'impegno, la dedizione, e la collaborazione che TÜV SÜD e Deka hanno messo sul campo, senza paure e senza incertezze, e che ora ci permette di assaporare assieme questo fantastico risultato che veniva raccontato da molti come impossibile. Ma la sfida per le cose impossibili e per le innovazioni sono anche gli elementi che accomunano gli attori di questa bellissima avventura. Un grazie particolare al team italiano di TÜV SÜD, che ha gestito in maniera ineccepibile questo progetto".Per Paolo Salvadeo, Amministratore Delegato di Deka e Direttore Generale della capogruppo El.En. SpA "il durissimo lavoro dei nostri team di progetto, della qualità, e del settore regolatorio, che si sono costantemente confrontati con gli esperti di TÜV SÜD, ha portato al raggiungimento dell'importante certificazione in MDR di molti dei nostri dispositivi di punta. Inutile negare la difficoltà nel raggiungere questo obiettivo molto stringente, ma non è la prima volta che Deka diventa pioniere. Lo ha dimostrato con tutte le innovazioni che hanno caratterizzato la sua attività in più di 30 anni di storia, ed ora nel mettere a segno questo importante progetto. Dal canto suo TÜV SÜD - continua - è riuscita brillantemente a districarsi nei vari meandri della complessità della norma europea, e Deka ha adeguato i propri prodotti e standard nella direzione del conseguimento dell'obiettivo. Sono pienamente soddisfatto".Il conseguimento della certificazione MDR permette a Deka di espandere ulteriormente la sua awareness sui mercati internazionali, offrendo ai suoi clienti prodotti che rispondono alle più rigide normative del settore medico e assicurando una significativa competitività nella sicurezza e nell'efficacia degli strumenti laser utilizzati. "Nel concorrenziale settore dei prodotti high-tech, infatti, è fondamentale rivolgere sempre l'attenzione alla ricerca e a soluzioni sicure per creare prodotti e tecnologie unici", conclude la nota.- foto ufficio stampa DEKA - Cerimonia di consegna del certificato MDR alla presenza dei vertici di TÜV SÜD e di DEKA, e di alcuni dirigenti, quadri e operatori della società DEKA coinvolti nel processo MDR -(ITALPRESS).fsc/com11-Lug-24 12:03. di Italpress   11-07-2024 - 12:03 Link copiato Commenti Leggi la Netiquette

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