Regulatory Affairs

Visbion is an ISO 9001:2000 and ISO13485:2003 registered company. These ISO standards combine to specify requirements for a quality management system that the company needs to comply with, in order to provide medical devices and related services that consistently meet customer and regulatory requirements. Visbion's ISO certificates are provided below.

Visbion's PACS software systems are certified for use in the EU according to the 93/42/EEC-Medical Device Directive. The certificate is provided below. 

For any additional information on our standards and certification, please email us at This e-mail address is being protected from spambots. You need JavaScript enabled to view it .

Attachments:
FileDescriptionFile size
Download this file (97128 - EC Declaration of Conformity Iss8.pdf)EC Declaration of Conformity 33 Kb
Download this file (SGS Directive 93 42 EEC Annex II.pdf)SGS Directive 93 42 EEC Annex II.pdf9342 EEC Certificate1300 Kb
Download this file (SGS ISO 13485 2003 UKAS Accredited.pdf)SGS ISO 13485 2003 UKAS Accredited.pdfISO 13485:2003 Certificate1207 Kb
Download this file (SGS ISO 9001 2008 UKAS Accredited.pdf)SGS ISO 9001 2008 UKAS Accredited.pdfISO 9001 Certificate1199 Kb
 


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