Our expertise covers the entire compliance journey for software and AI systems in healthcare.
Classification, gap analysis, MDR / IVDR / AI Act roadmap.
Technical File, QMS ISO 13485, Notified Body audit management.
Setup and maintenance of a digital, living, and compliant 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 health software companies.
Guided classification of your device and your regulatory maturity.
Continuous regulatory watch to track regulatory changes.
Query your QMS in natural language, instant access to answers.
Anticipate the audit, identify gaps before they become non-conformities.
We support healthcare software publishers in their regulatory compliance journey.