NEW! Online-Certificate Course: Specialist for AI-based Medical Devices and IVD

Unlock the Future of Healthcare!

On February 19th, 2026, the second round of our compact online course on all regulatory requirements for AI-based medical devices and in vitro diagnostics (IVD) devices will start. The course will be taught in English!

With this recognized certificate you can prove your qualifications and competences in the field of AI-based medical devices and IVD!

5 modules = 5 afternoons (13:30-17:30 – ONLINE): 19.02.-18.03.2026

Upon completion of the course and passing the online exam, you will receive a certificate!

Shaping the Future of AI-driven Healthcare Innovation!

Gain practical insights into regulatory pathways, cutting-edge compliance strategies, and international best practices. Whether you’re a developer or regulatory professional, this course will empower you to bring innovative AI-driven solutions to market safely and efficiently.

Enroll now to stay ahead in the rapidly evolving world of medical technology!


YOUR BENEFIT as a specialist for AI-BASED MEDICAL DEVICES AND IVD

  • Regulatory Expertise: In-depth knowledge of EU and US regulations – including MDR, IVDR, and FDA requirements – to guide you safely through the approval process.
  • Faster Market Entry: Reduce risks and accelerate your approval timeline with expert compliance strategies tailored to your technology.
  • Interdisciplinary Strength: Seamless integration of regulatory, technical, and clinical perspectives for sustainable success in a regulated environment.

Book now to bring your AI innovation to market – compliant, effective, and future-ready!


CONTENT

Module 1 AI-BASED MEDICAL DEVICES: Navigating European Regulations MDR and IVDR 19.02.2026, 13:30-17:30
Module 2 AI-BASED MEDICAL DEVICES: Navigating FDA Regulations in USA 26.02.2026, 13:30-17:30
Module 3 AI-BASED MEDICAL DEVICES: Mastering Riskmanagement 05.03.2026, 13:30-17:30
Module 4 AI-BASED MEDICAL DEVICES: Post-Market Surveillance and Change Management 12.03.2026, 13:30-17:30
Module 5 AI-BASED MEDICAL DEVICES: NIS2 Requirements and ISO 27001 18.03.2026, 13:30-17:30

Single modules also available!

Download PDF-Flyer!


PARTICIPANTS

  • Manufacturers of medical devices planning to integrate artificial intelligence into their products,
  • 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
  • Consultants for medical devices
  • Newcomer & Start-Ups

COSTS

  • Early bird (up to 4 weeks before the start date): Euro 1.175,- (excl. VAT)
  • Standard: Euro 1.295,- (excl. VAT)
  • incl. seminar documents as PDF and a certificate of participation

DISCOUNTS

10% discount for

  • Cluster members (Standortagentur Tirol, Bayern Innovativ, Human.technology Styria, LISAvienna, MTC Oberösterreich, Innovation Salzburg, ecoplus NÖ)
  • from the 2nd participant of a company/organization
  • for returning visitors
  • The discounts cannot be combined.
  • All seminar discounts at a glance

CONCLUSION OF THE ONLINE COURSE

The course concludes with an online exam (multiple choice) and an individual final discussion on the contents of all modules. After successfully passing the exam, you will receive your personal certificate.

With this recognized degree, you provide proof of qualification and competence in the field of AI-based Medical Devices and IVD!

LOCATION: 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.

BOOK NOW

If you have any questions, please do not hesitate to contact us:

Mag. (FH) Christa Bachinger-Hauk
en.co.tec-Akademie
Mail: seminare@encotec.at or
phone: +43 1 8863491

Download PDF-Flyer!