EU MDR/IVDR
European Compliance Simplified.
We provide comprehensive support for EU MDR and IVDR compliance,
helping you navigate the complex European regulatory landscape effectively.
Technical Documentation
We prepare compliant documentation for CE marking of all device types:
Technical documentation structured to MDR/IVDR requirements
General Safety and Performance Requirements (GSPR) compliance
Risk management documentation
Clinical evaluation documentation
Labeling and IFU requirements
Post-Market Systems
We establish robust post-market processes:
Post-Market Surveillance (PMS) plans
Post-Market Clinical Follow-up (PMCF) plans and reports
Periodic Safety Update Reports (PSUR)
Vigilance reporting processes
Documentation maintenance systems
QMS & EUDAMED
We support operational compliance requirements:
QMS procedures and forms aligned with MDR/IVDR
EUDAMED registration assistance
Economic operator requirements
Notified Body submission preparation
Ongoing compliance
Our clients and partners
