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Marken Singapur erhält Qualitätsmanagementzertifizierung
Date:12/5/2013

RESEARCH TRIANGLE PARK, North Carolina, 5. Dezember 2013 /PRNewswire/ -- Marken gab heute bekannt, dass die Anlage für den Bau biologischer Kits in Singapur nun nach dem ISO 13485 Standard der International Standards Organization (ISO) für die Lagerung und Verteilung medizinischer Geräte zertifiziert ist.

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Die Zertifizierung bestätigt, dass Marken über ein Qualitätsmanagementsystem für sterile und nicht sterile medizinische Gerätekits verfügt, die in der Anlage für den Bau biologischer Kits in Singapur zusammengestellt werden. Marken erhielt die Zertifizierung nach einem 2-tägigen, intensiven Audit und der Verifizierung, dass das Lager die ISO-Anforderungen an konsistente Qualität, Leistung der Prozesslenkung und ein effektives Dokumentationssystem erfüllt. Die ISO 13485 Zertifizierung erfolgte zusätzlich zur bestehenden 9001 Zertifizierung von Marken in Singapur, welche die Anforderungen an laufende Verbesserungen und Kundenzufriedenheit einschließt. Das Lager von Marken in Singapur ist strategisch gelegen und bietet der Branche für klinische Studien die regionale Verteilung pharmazeutischer Produkte und medizinischer Geräte.

Gerit Offenhauser, Senior Vice President, Clinical Trials Distribution, kommentierte dies wie folgt: „ISO 13485 ist ein weiterer Schritt von Marken, um das Engagement für unsere Kunden zu beweisen. Diese Zertifizierung stellt Transparenz in unserer Produktion biologischer Kits in Singapur her. Unsere Kunden können nun vollständig darauf vertrauen, dass unsere Anlage ihre Anforderungen an die Fähigkeit von Marken, Kits zusammenzustellen, zu lagern und zu verteilen, un
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