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JiveX Certificates

Service and quality rank very high for VISUS - enabling you to deliver best possible diagnostics to your patients. In order to safeguard our own quality requirements, we have installed a comprehensive and universal quality management. It includes, for example, a multitude of certifications which ensure the functioning of our solutions, also in our partner network.

 

 Following you will find many certificates which assure the quality of VISUS.

 

 

Download Declaration of Conformity

SC_Certificates_CE_Conformity.pdf

CE Declaration of Conformity

129 K 23.01.2012

Download Certificate ISO 13485:2003

SC_Certificate_13485_CMDCAS.pdf

Certificate ISO 13485:2003

337 K 23.01.2012

Download ISO Certificate 9001:2008

SC_Certificate_ISO9001_2008_EN.pdf

ISO Cerficate 9001:2008

284 K 23.01.2012

Download EG Certificate

SC_Certificate_EG_EN.pdf

Full Quality Assurance System
Annex II, section 3 of the Directive 93/42/EEC on Medical Devices

599 K 23.01.2012

Download EN ISO 13485:2003/AC:2007

SC_Certificate_13485_EN.pdf

EN ISO 13485:2003/AC:2007
Language: EN/DE

595 K 23.01.2012

Download Certificate of Marketability

CertificateMarketability_2010_02_12.pdf

Certificate of Marketability according to ยง34(1) of the Medical Devices Law (MPG).
Language: EN/DE

1015 K 23.01.2012

Download FDA Certificate

SC_Certificate_FDA_Letter.pdf

FDA Certificate

84 K 23.01.2012

Download Certificate Canada Device

SC_Certificate_CanadaDeviceLicence.pdf

Certificate Canada Device

370 K 23.01.2012

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