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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 GOST-R Declaration of Conformity

SC_Certificate_GOST-R_RU.pdf

GOST-R Declaration of Conformity for Russia

2 M 21.02.2012

Download Russia Registration Certificate

SC_Certificate_RegistrationCertificate_RU.pdf

Registration Certificate for the Russian market

3 M 21.02.2012

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

618 K 21.02.2012

Download ISO Certificate 9001:2008

SC_Certificate_ISO9001_2008_EN.pdf

ISO Cerficate 9001:2008

753 K 21.02.2012

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

682 K 21.02.2012

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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