Description
The third round of our compact online course on all regulatory requirements for AI-based medical devices and in vitro diagnostics (IVD) devices will start in May 2026!
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.
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!
CONTENT
| Module 1 | AI-BASED MEDICAL DEVICES: NIS2 Requirements and ISO 27001 | 13.05.2026, 13:30-17:30 |
| Module 2 | AI-BASED MEDICAL DEVICES: Navigating European Regulations MDR and IVDR | 20.05.2026, 13:30-17:30 |
| Module 3 | AI-BASED MEDICAL DEVICES: Navigating FDA Regulations in USA | 03.06.2026, 13:30-17:30 |
| Module 4 | AI-BASED MEDICAL DEVICES: Mastering Risk Management | 10.06.2026, 13:30-17:30 |
| Module 5 | AI-BASED MEDICAL DEVICES: Post-Market Surveillance and Change Management | 17.06.2026, 13:30-17:30 |
Single modules also available!
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
- Newcomers & 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, Forum Medtech Pharma, Human.technology Styria, LISAvienna, MTC Upper Austria, Innovation Salzburg, ecoplus NÖ, Bayern Innovativ)
- 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.
