Standards & Certificates

Legal requirements

The highest priority at Telemis is patient safety. Telemis fulfills international legal requirements:

• ISO 13485  (PDF)
• CE Mark Med 31584 (PDF)
• FDA (PDF)
• Declaration of conformity (PDF)

Standards

Furthermore Telemis is compliant with existing standards such as IHE, DICOM and HL7:

• IHE Integration Statement (PDF)
• DICOM Conformance Statement (PDF)
• HL7 Statement (PDF) 

Certificates

The TM-Mammo has also been certified for EU Breast Cancer Screening programs by the Belgian and French authorities:

TM-Mammo certification Belgium:

• Certificate of the Flemish Governement
• Certificate of the Brussels Government
• Certificate of the Walloon Government

TM-Mammo certification France:

• Not applicable

Local accreditations

Amendment No. 24 in France:

On December 21, 2007, CNAM (the National Health Insurance Fund) included Telemis on its list of companies meeting the specifications for a picture archiving and management system (attached to amendment No. 24 to the National Health contract). CNAM informed the French local health insurance funds of this by means of an internal circular. Private clinics and medical imaging centers in France which wish to benefit from supplements for digital medical image archiving can now ask Telemis for an approved installation.