Regulatory: Med Dev Software compliance

Training format

Topic

  • Next: 25-29 Jan 2027 Live online
  • Also: 5-9 Jul 2027 Live online

Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations

Live online

An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.

  • 30 CPD hours Focused
  • Presented by Koen Cobbaert
  • and Zuzanna Kwade
Course info 
  • Next: 8-9 Dec 2026 Live online
  • Also: 28-29 Jun 2027 Live online
  • Also: 7-8 Dec 2027 Live online

Masterclass: Market Authorisation of AI-enabled Medical Devices

Live online

This course provides essential guidance on navigating regulatory requirements and securing market authorisation for AI-based medical devices, covering key regulations, compliance strategies, and best practices for global market access.

  • 12 CPD hours Focused
  • Presented by Koen Cobbaert
Course info 
  • Next: 30 Nov-1 Dec 2026 Live online

Global Market Access for Medical Device Software

New for 2026

Live online

Navigate global market access for medical device software with insights on international regulations, reimbursement strategies, and Health Technology Assessment (HTA) to improve your product’s chances of commercial success

  • 6 CPD hours Focused
  • Presented by Catarina Carrao
Course info