Training Modules
12 modules — approx. 6 hrs total
Clinical Engineering in European Hospitals
Why Engineers Matter
The engineers and technicians hospitals cannot work without — why clinical engineers are essential for MDR/IVDR compliance.
Core
MDR/IVDR Basics
Fundamental regulations and key changes
20 min
Core
Device Classification
Classifying medical devices and IVDs
30 min
Core
IVDR Essentials
IVD classification, companion diagnostics & more
40 min
Core
HCW Responsibilities
Your role in device safety and incident reporting
25 min
Core
PMS & Vigilance
Post-market surveillance & incident reporting
35 min
Core
Conformity Assessment
Notified Bodies, technical docs & CE marking
35 min
Core
Clinical Evaluation
Performance evaluation, investigations & PMCF
35 min
Core
SaMD & Cybersecurity
Software as Medical Device & EUDAMED/UDI
35 min
Core
Economic Operators & PRRC
Supply chain obligations & PRRC (Art. 10–16)
30 min
Advanced
Risk Management (ISO 14971)
Risk process, matrix, controls & benefit-risk
35 min
Practical
Hospital Integration
Working with compliance systems
15 min
Assessment
Knowledge Check
Test your MDR/IVDR understanding
30 min