RAPS Workshop: Navigating AI Medical Device Regulations: Global Strategies and Early Engagement

This workshop is designed to help regulatory and product development teams successfully bring AI/ML-enabled medical devices to market. You will learn global reg. perspectives from the US FDA, EU MDR and China NMPA.

10am – 2pm EST 12 November 2026 + Add to calendar

As artificial intelligence (AI) and machine learning (ML) continue to transform healthcare, regulatory professionals must navigate increasingly complex and rapidly evolving global requirements. This workshop provides a unified, comprehensive guide to both international regulatory frameworks and early regulatory engagement strategies, equipping participants with the tools to bring AI/ML-enabled medical devices to market efficiently and compliantly.

Participants will explore the regulatory landscapes of the US FDA, EU MDR, and China NMPA, comparing classification pathways, documentation expectations, clinical evidence requirements, and key guidance documents. The workshop also emphasizes the critical role of early and continuous regulatory affairs (RA) involvement in AI product development, demonstrating how proactive regulatory strategy can reduce risk, streamline design decisions, and prevent delays in FDA submissions.

Drawing from real-world case studies and FDA interactions, the session will highlight common pitfalls—such as data quality issues, insufficient algorithm validation, and gaps in cybersecurity or change management documentation—and show how early planning can avoid them. Attendees will learn practical methods for aligning technical teams with regulatory expectations, integrating ethical and data governance considerations, and building robust submissions tailored to each region.

This workshop is designed for regulatory professionals, R&D leaders, and cross‑functional teams who want to stay ahead of global AI regulatory trends and accelerate successful market entry through smarter, proactive regulatory strategy.

Learning Objectives

Upon completion of this workshop, participants will be able to:

Understand the classification and regulatory pathways for AI/ML medical devices in the US, EU, and China.
Formulate integrated global regulatory strategies that combine early engagement with region-specific submission planning.
Incorporate regulatory strategy early into design and development to minimize risks and avoid late-stage deficiencies.
Identify key regulatory documents, standards, and guidances influencing AI-based device development globally.
Equip R&D teams with tools and training to ensure algorithm design, datasets, validation, and change management practices meet FDA expectations.
Understand the main milestones in AI development and how these align with the regulatory process.
Better understand common pitfalls in the FDA review process for AI-based medical devices.
Navigate essential cybersecurity requirements for AI/ML submissions.

Who Should Attend?

Regulatory Affairs professionals involved in, or interested in, AI-based medical devices
R&D team members working on AI/ML-enabled medical technologies
Product managers and cross-functional leaders overseeing AI medical device development
Professionals seeking to understand global regulatory frameworks (FDA, EU MDR, China NMPA)
Regulatory intelligence
Start-up VPs, CEOs
Policies and governance affairs

Audience Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Agenda

Time ET	Topic	Duration
10:00 – 10:10 am	Part 1 Opening: Global Landscape Overview	Grace F. Palma, CN
10:10 – 10:50 am	Part 2 Cybersecurity Section	Theodore Nicholson, US
10:50 – 11:20 am	Part 3 EU Regulatory Framework	Andrea Biasiucci, EU
11:20 – 11:50 am	Part 4 China Regulatory Landscape	Viki Chen, US
11:50 – 12:05 pm	Break
12:05 – 1:15 pm	Part 5 U.S. FDA and Canada Health: From Design Control to Submission	Tal Bresler-Stramer, US
1:15 – 1:40 pm	China Regulatory Landscape	Yan Sheng, US
1:40 – 2:00 pm	Final Q &A	All Presenters

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 [email protected]. 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 [email protected] with the event title, name of the original registrant and the contact information for the new attendee.