The rapid adoption of artificial intelligence (AI) in medical devices and regulatory processes has introduced new opportunities as well as regulatory challenges. With the EU AI Act having entered into effect in February 2025, organisation with MedTech professionals must ensure literacy of staff under the AI Act and compliance of AI integration and outcomes with the existing MDR/IVDR frameworks.
This interactive virtual seminar will provide practical strategies for integrating EU AI Act requirements into established quality management systems (QMS) and for preparing unified technical documentation. Attendees will also explore tools and organizational strategies to support the responsible and compliant use of AI for regulatory applications in the MedTech and IVD domains.
Key Topics
- Understanding the EU AI Act and its implications for MedTech and how to convey this to the organisation users of AI
- Integrating AI Act requirements into MDR/IVDR quality management systems
- Preparing unified technical documentation for compliance with both frameworks
- Managing AI lifecycle oversight, including post-market monitoring, change management, and continuous compliance under the EU AI Act and MDR/IVDR
- Evolving organizational roles for AI governance and regulatory oversight
Registration Fees & Deadlines
Member: $20|Nonmember: $30|Student Members: $0 | Student Nonmembers: $0 (With Promo Code)
*Please reach out to a RAPS Southern California LNG Leader to request a Student Promo Code
Learning Objectives
Participants will be able to:
- Understand how the EU AI Act aligns with MDR/IVDR and identify overlapping requirements related to QMS, data governance, and human oversight
- Integrate AI Act requirements into existing MDR/IVDR quality systems to streamline compliance and avoid duplication
- Prepare unified technical documentation that satisfies both AI Act and MDR/IVDR expectations
- Implement effective AI lifecycle oversight, including post-market surveillance, model updates, retraining controls, and change management
- Strengthen organizational readiness by adopting AI-driven compliance tools and defining clear roles for AI governance and regulatory oversight
Who Should Attend?
Quality, regulatory, and operations supervisors, managers, directors, vice presidents, and other professionals involved in medical device compliance, risk management, and the implementation of AI in MedTech.
Audience Learning Level
Intermediate
Designed for participants with basic knowledge of MedTech regulatory frameworks and AI technologies. The session introduces higher-level concepts and includes practical exercises and real-world examples.
Speakers
Internationally recognized expert in medical device regulatory affairs and conformity assessment, with extensive experience in the practical application of MDR, IVDR, and EU AI Act requirements.
Renowned legal expert in EU medical device law and the intersection of AI regulation and regulatory compliance.
Michael Konings
Senior Director and Global Head of Regulatory Affairs, IGT Systems, Philips
Specialist in organizational impact and the responsible use of AI in healthcare technology.
Leader in AI governance, focusing on responsible adoption and organizational readiness within the MedTech industry.
Dina Lakayan (Moderator)
Senior Regulatory Consultant and CEO, CREATE Regulatory
Specialist in regulatory affairs and AI compliance.
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email
support@raps.org.