Our expertise covers the entire compliance journey for healthcare software and AI systems.
Classification, gap analysis, MDR / IVDR / AI Act roadmap.
Technical File, ISO 13485 QMS, Notified Body audit management.
Setup and maintenance of a living, compliant digital QMS.
MDR 2017/745 and ISO 13485 audits conducted by GMED-certified auditors.
Gap analysis and requirements assessment for ANS compliance.
A suite of tools designed for regulatory and quality teams at healthcare software companies.
Guided classification of your device and regulatory maturity.
Continuous regulatory monitoring to track evolving regulations.
Query your QMS in natural language for instant answers.
Anticipate audits and identify gaps before they become non-conformities.
We support healthcare software publishers in their regulatory compliance journey.