Certificates - MetaSystems | MetaSystems

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Certificates

Certificate EN ISO 13485:2010 (German version)
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File Size: 309.56 KB	File Date: May 04, 2011 14:13	Hits: 113

Certificate EN ISO 13485:2010 (English version)
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File Size: 304.72 KB	File Date: May 04, 2011 14:16	Hits: 180

Certificate EN ISO 13485:2010 (French Version)
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File Size: 382.99 KB	File Date: Jun 01, 2011 14:40	Hits: 188

EU Conformity Declaration for XA Aneuploidy Probe Kits (English version)
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File Size: 1006.96 KB	File Date: Jan 31, 2012 09:30	Hits: 147

EU Conformity Declaration for XA Aneuploidy Probe Kits (German version)
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File Size: 1.04 MB	File Date: Jan 31, 2012 09:31	Hits: 186

Customer Built Systems
According to EC directive 98/79, Article 1 (5), health institutions can disclaim the CE mark, if a device is manufactured and used only within the same institution and on the premises of the manufacturer or used on premises in the immediate vicinity without having been transferred to another legal entity. The EC directive does not affect the right of a Member State to impose further restrictive measures. In practice, a CE mark is not required, if the institution is both manufacturer and user (for example, an IT department or a technician can build the systems). Download a form required to acknowledge that you are aware of the restrictions for systems with customer components.
File Size: 108.79 KB	File Date: Nov 11, 2011 09:13	Hits: 103

FAQ on CE Mark and ISO Certificate for MetaSystems Imaging Products
This document outlines MetaSystems position on using computer hardware other than specified in the quotations made by MetaSystems. Download this document.
File Size: 184.49 KB	File Date: Nov 30, 2011 13:56	Hits: 197

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