Legal requirements
The highest priority at Telemis is patient safety. Telemis fulfills international legal requirements:
- ISO 13485 (PDF)
- CE Mark Med 31584 (PDF)
MDR transition (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)