Robust compliance to meet
your needs

iMDsoft has attained an extensive list of certifications and attestations to comply with global compliance standards.

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
HIPAA

HIPPA compliant