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Regulatory

Visbion is an ISO 9001 and ISO 13485 certified 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.

DICOM Statements

The documents provided below state the conformance of Visbion’s DICOM technology to the DICOM 3.0 standard. They have been written for software developers and system integrators who are interested in integrating Visbion’s solutions and products with existing DICOM 3.0 conformant devices.

IHE Statements

The documents provided below state the conformance of Visbion’s products to the IHE standard. They have been written for software developers and system integrators who are interested in integrating Visbion’s solutions and products within an IHE compliant healthcare IT system.

HL7 Statements

The document provided below describes the implementation details of the HL7 interface to Visbion PACS

Health Level Seven (HL7) is an approved standard for the exchange of data between medical systems dealing with clinical and administrative data.