Regulatory, safety and compliance
EU MDR 2017/745
Class IIb certified
MHRA registered Medical Device Class IIb
21CFR820 US FDA Class II
US Food and Drug Administration Medical Device 510k # K230214
ISO certifications
ISO 13485: 2016 certified (Medical Devices: Quality Management Systems)
ISO 27001: 2022 certified
Data protection / infosec
Committed to GDPR compliance
NHS Registration on Data Security and Protection Toolkit
CyberEssentials / CyberEssentials Plus





