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.
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GOST-R Declaration of Conformity for Russia |
2.3 M | |
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SC_Certificate_RegistrationCertificate_RU.pdf Registration Certificate for the Russian market |
2.6 M | |
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SC_Certificates_CE_Conformity.pdf CE Declaration of Conformity |
236 K | |
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SC_Certificate_13485_CMDCAS.pdf Certificate ISO 13485:2003 |
618 K | |
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SC_Certificate_ISO9001_2008_EN.pdf ISO Cerficate 9001:2008 |
753 K | |
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Full Quality Assurance System Annex II, section 3 of the Directive 93/42/EEC on Medical Devices |
599 K | |
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EN ISO 13485:2003/AC:2007 Language: EN/DE |
682 K | |
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CertificateMarketability_2010_02.pdf Certificate of Marketability according to ยง34(1) of the Medical Devices Law (MPG). Language: EN/DE |
1.0 M | |
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FDA Certificate |
84 K | |
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SC_Certificate_CanadaDeviceLicence.pdf Certificate Canada Device |
370 K |