Medical devices


Fulfilling the requirements of CE marking is inconceivable without acquiring the appropriate knowledge. We provide training in all relevant areas related to CE marking of medical devices in the form that best suits your needs: open and outsourced or custom- ized training.


Standard, legislation, guidance


ISO 13485 Standard introductory training
ISO 9001, 14001 Standard introductory training
ISO 13485 Internal Auditor Training
ISO 9001, 14001 Internal Auditor Training
MDR II., III. Technical documentation
MDR 15.  Person Responsible for Regulatory Compliance (PRRC)
MDR XIV. Clinical Evaluation
MDR III. Post-market surveillance system (PMS)
MDR XIV. B. Post-market clinical follow-up (PMCF)
MDR/IVDR Cybersecurity
ISO 14971 Risk management
EN 62366-1 Usability Engineering
EN 60601-1 Safety test of medical electrical equipment
EN 61010-1 Electrical equipment for measurement, control, and laboratory use
EN 61010-2-101 In vitro diagnostics (IVD) medical equipment
2006/42/EK CE marking of machines


EN ISO 10218-X

ISO/TS 15066

ICE marking of industrial robot and collaborative robot systems
EN ISO 12100 Risk evaluation of industrial machines
(relevant standards) Safety and technical requirements of machines
MDR We offer 2 hours of preparatory training (including 15 minutes of consultation)