Interactive Training
Interactive Lessons
Structured modules covering the EU regulatory framework for medical devices. Each lesson combines explanatory content with quizzes and exercises to reinforce your understanding.
Regulatory Foundations
Understand the EU regulatory landscape for medical devices — who the key players are, what the regulations require, and how MDR and IVDR fit together.
MDR Classification Mastery
Master all 22 classification rules in MDR Annex VIII. Learn to classify any medical device by understanding the logic behind each rule.
Conformity Assessment Pathways
Learn which conformity assessment route applies to each device class, and how to navigate Annexes IX through XI.
Technical Documentation
Build compliant technical documentation per Annexes II and III — from device description through clinical evaluation and SSCP.
Quality Management System
QMS requirements under the MDR, ISO 13485 alignment, design controls, CAPA processes, and operational implementation.
Post-Market Surveillance
PMS obligations, vigilance reporting, PMCF studies, and periodic safety update reports.
Device-Type Certification Tracks
End-to-end certification walkthroughs for specific device types — Class I through III, including SaMD.
IVDR Foundations
The IVDR classification system, performance evaluation requirements, and conformity assessment routes for IVDs.
IVDR Device-Type Tracks
Certifying IVDs from Class A general-purpose devices through Class D blood-screening reagents.
International Regulatory Context
Global regulatory landscape for medical devices — FDA pathways, MDSAP, Health Canada, and strategies for multi-market access.