Accreditations and Regulation

Certificate Number: MD19.8146 ISO 13485:2012
Cert number MD19.8146
ISO 13485:2012

ISO 13485 – Certified

IEC 62304 – Conformance

ISO 27001 – Conformance

Class 1 Medical Device

Approved by the HPRA (Irish Medicines Board)

CE – Certified

CSIS Health IGSoC – approved Commercial Third Party (CTP)

IGSoC

Approved Commercial Third Party (CTP)

Compliant to N3 Network Security