Basic-course: AI-BASED MEDICAL DEVICES and IVD: Navigating European Regulations MDR and IVDR

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Kalender
Tickets
Wann:
6. November 2025 um 13:30 – 17:30
2025-11-06T13:30:00+01:00
2025-11-06T17:30:00+01:00
Wo:
ONLINE
Preis:
€ 305,-
Kontakt:
E-Mail
FH & Universitäten Gesundheitswesen Medizintechnik Produktentwicklung Regulatory Affairs

AI is reshaping the future of medical technology—but how do you stay compliant in a rapidly evolving regulatory landscape? Europe applies one of the world’s most comprehensive frameworks to guarantee the safety, performance, and transparency of medical devices and IVDs, especially those powered by disruptive technologies like AI.

By the end of this seminar, you will have essential insights into MDR, IVDR, and the latest guidance on AI integration. Learn how to align your innovation with EU expectations, avoid regulatory pitfalls, and accelerate your path to market.

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:

Regulations for AI-based Medical Devices and IVD in Europe

  • Overview of the most important concepts and terms in AI
  • Regulations in Europe
    • EU-Regulations for medical devices (MDR) and In-vitro Diagnostics (IVDR),
    • EU-AI-Act: Harmonized rules for placing AI systems on the European market
    • ISO 13485 – Quality management systems for medical devicessystems — Requirements for regulatory purposes
    • IEC 62304 – Software life cycle processes for medical device software
    • MDCG – Practical guidance documents from the Medical Device Coordination Group
    • IMDRF – International guides for global harmonization of medical device regulations
    • IG-NB – Structured questionnaire for assessing AI in medical devices, aiding notified bodies‘ evaluation
  • Exercise:
    • Regulatory documentation assessment using the IG-NB questionnaire

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.

Click here to book now!

For questions: office@encotec.at or +43 1 8863491