Robust compliance to meet
your needs

ISO

ISO 13485:2016 certified

ISO27001

ISO 27001:2022 certified

EU MDR

CE-certified in accordance with EU MDR (2017/745)

MDSAP

Medical Device Single Audit Program (MDSAP) certified

TGA

Australian Register of Therapeutic Goods (ARTG) listed

Health Canada

Health Canada Medical Devices Active Licence Listing (MDALL)

GDPR

EU General Data Protection Regulation (GDPR) compliant

ENS

Spanish National Security Framework (Esquema Nacional de Seguridad -ENS) certified.

Cyber Essentials

Cyber Essentials certified

Cyber Essentials Plus

Cyber Essentials Plus certified

HIPPA

HIPPA compliant