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)
Upon completion of the course and passing the online exam, you will receive a certificate.
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.
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.
Agenda
- AI-BASED MEDICAL DEVICES: NIS2 Requirements and ISO 27001 13.05.2026, 13:30-17:30
- AI-BASED MEDICAL DEVICES: Navigating European Regulations MDR and IVDR 20.05.2026, 13:30-17:30
- AI-BASED MEDICAL DEVICES: Navigating FDA Regulations in USA 03.06.2026, 13:30-17:30
- AI-BASED MEDICAL DEVICES: Mastering Riskmanagement 10.06.2026, 13:30-17:30
- AI-BASED MEDICAL DEVICES: Post-Market Surveillance and Change Management 17.06.2026, 13:30-17:30