Accreditations and Regulation

iso-13485

Cert No: 51983/A/0001/UK/EN 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