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Noser Engineering AG erweitert sein Medizintechnik-Portfolio im Hinblick weltweiter Regulierungsauflagen und verkürzt die Zeit bis zur Markteinführung
Date:11/19/2013

nehmen, die Herausforderungen einer schnellen Produktentwicklung zu meistern, da Funktionalität schneller zu Software als zu Hardware hinzugefügt werden kann", so Dr. Michael Eisenring, Manager Embedded Systems bei der Noser Engineering AG. "Innovation, Qualität und Kostenbewusstsein sind alles wichtige Antriebskräfte auf dem globalen Gesundheitsmarkt wie auch die Suche nach einer Balance zwischen der Erfüllung weltweiter Regulierungsauflagen auf der einen Seite und einer schnelleren Markteinführung auf der anderen Seite."

Die Noser Engineering AG entwickelt Software und Elektronik gemäß der Medizinproduktrichtlinie 93/42/EEC und der Richtlinie 98/79/EC für In-vitro-Diagnostika.

Noser Engineering gewährleistet, dass Software die Standards der IEC-Richtlinie 62304 erfüllt. Verwendbarkeit und Systemanforderungen für die Spezifikation und Implementierung der Benutzeroberfläche sowie das Testen und die Gebrauchsprüfung werden gemäß IEC 62366 umgesetzt.

Noser Engineering entwickelt Elektronik gemäss den allgemeinen Standards von IEC 60601-1 wie auch den geltenden Ergänzungsnormen von IEC 60601-1 x. Falls erforderlich oder angemessen, können auch Methoden der Funktionalen Sicherheit gemäss IEC 61508 implementiert werden, um die Integrität der erforderlichen Sicherheitsniveaus zu erreichen und zu demonstrieren.

Projektmanagement, Qualitätsmanagement und Risikomanagement werden unter Anwendung des V-Modells und SCRUM für das Projektmanagement, ISO 13485 für das Qualitätsmanagement, und ISO 14971 zur Unterst&#
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SOURCE Noser Engineering AG
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