Speaker: Somashekara Koushik Ayalasomayajula, Quality and Regulatory Affairs Director
Date: October 31st 2024, Online
Duration: 4 hours | 9:00 AM – 1:00 PM (EDT), 2:00 PM – 6:00 PM (CET)
About the Speaker: Somashekara Koushik Ayalasomayajula is a polymer engineer and an experienced quality and regulatory affairs consultant with 11+ years of expertise in regulated industries. Besides leading the Digital Health team, he stands ready to guide organizations through the complexities of quality and regulatory affairs, ensuring excellence in the evolving landscape of medical devices globally. Koushik is an ASQ-certified Medical Device Auditor (ASQ-CMDA) and holder of RAC Devices from RAPS.
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 the impact of AI regulations on EU medical device regulations
Training Content:
- Introduction to EU Artificial Intelligence Act (EU AIA)
- Overview of the regulations
- Subject matter and scope
- Key provisions
- Compliance requirements for general-purpose AI systems
- Risk-based classification & prohibited AI practices
- Obligations of providers, importers, distributors and users
- Conformity assessment
- Harmonised standards
- Conformity assessment routes
- EU Declaration of Conformity
- 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:
- Presentation with interactive discussions
- Exercises during the training
- End of training assessment (participants will receive a training certificate)
Who Should Attend:
- AI developers, Product managers and Project leaders.
- Quality and Regulatory affairs employees of medical device manufacturers involving AI.
- Anyone seeking to understand the regulatory requirements of their AI product that falls under the definition of a medical device (under Medical Device Regulation [MDR] 2017/745 in Europe).
Prerequisite:
Basic understanding on EU medical device regulatory framework
Price:
EUR 415 including course material, recording and certificate