Stay compliant. Stay in control – beyond market launch. AI doesn’t stop evolving after approval – and neither should your regulatory strategy. This compact seminar gives you the essential tools to manage Post-Market Surveillance (PMS) and Change Management for AI-based medical devices and IVDs under EU MDR/IVDR and the upcoming EU AI Act.
Learn how to monitor real-world performance, manage AI model changes (including re-training and change notifications), and fulfill your reporting obligations. Gain clarity on your interactions with notified bodies and regulatory authorities – and ensure your AI-powered products remain safe, effective, and market-ready.
Participants:
Regulatory Affairs Manager, Quality Management Specialist / QMS Manager, Legal Compliance Officer, Product Manager – Medical Devices / IVD, R&D Manager – AI-Based Medical Technologies, Post-Market Surveillance (PMS) Specialist, Clinical & Regulatory Strategist, Risk Management Specialist, Software as a Medical Device (SaMD) Expert, Internal or External Auditor – MDR, IVDR, ISO 13485
This basic course is part of our online course: DEVELOPING AI-BASED MEDICAL DEVICES AND IVD IN COMPLIANCE WITH REGULATIONS.
Seminar contents:
Post-Market Surveillance and Change Management for AI-based Medical Devices and IVD
- Post-Market Surveillance and Change Management acc. to EU AI Act and MDR/IVDR
- Monitoring and assessing risks after market launch
- Dealing with changes to the AI model (change notification, re-training),
- Reporting obligations and interaction with notified bodies and authorities
Your Trainer
DI Martin Schmid, Managing Director & Senior Consultant, en.co.tec Schmid KG
Costs:
- Early bird (until 4 weeks before the seminar): Euro 260,- (excl. VAT)
- Standard (starting 4 before the seminar): Euro 305,- (excl. VAT)
- incl. seminar documentation as PDF and certificate of participation
- All seminar discounts at a glance
EVENT LOCATION: LIVE-ONLINE!
You will receive the course documents and a link to the virtual seminar room via email in a timely manner. Each module is designed to be interactive, similar to a face-to-face seminar. You can ask the lecturer questions, complete exercises, and exchange ideas with the other participants.
For questions: office@encotec.at or +43 1 8863491
