Artificial Intelligence in Medical Device Industry
October 31st, Online
9:00 AM– 1:00 PM US Eastern Standard Time / 2:00 – 6:00 PM Central Europe Time

Duration: 4 hours
Speaker: Somashekara Koushik Ayalasomayajula

Training objectives:

● Understand the scope and structure of EU AI Act
● Understand risk-based approach and related obligations
● AI Quality Management approach to reach compliance, scaling responsible use for AI
● Understand impact of AI regulations on EU medical device regulations.

Training content:

● Introduction to EU Artificial Intelligence Act (EU AIA)
o Overview of the regulations
o Subject matter and scope
o Key provisions
● Compliance requirements for General purpose AI systems
● Risk based classification & prohibited AI practices
● Obligations of providers, importers, distributors and users
● Conformity assessment
o Harmonized standards
o Conformity assessment routes
o EU Declaration of Conformity
o CE marking of conformity
● AI regulatory sandboxes
● EU Database for high-risk AI systems
● Implementation timelines
● Interplay with EU Medical Device regulations (MDR/ IVDR)


Training format:

• Presentations with interactive discussions
• Group and individual exercises
• End of training assessment