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

Registration Fees & Deadlines

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

Speakers

Grace F. Palma, MBA
Principal, China Med Device

Grace Fu Palma is the principal of China Med Device, part of the global market access platform, Accel Groups with offices in US, China and Japan. With representations in key countries, Accel Groups provides one-stop solutions for medical device/IVD companies to enter key countries market with regulatory, clinical, and commercial services. Grace is a seasoned bilingual and bicultural MedTech executive, specializing in China and US regulatory and commercialization services. She has 30 years of experience driving global and China business strategy, regulatory, clinical evaluation and trials, commercialization, partnerships, for both large multinationals and startup companies. She started China Med Device (CMD) in 2011. She has been personally involved in launching hundreds of medical devices in the US and China market. She has extensive network of clinical, regulatory and industry contacts. She founded Chinese American Heart Association in 2005 and Chinese Eye Care Alliance Group. She grew up in Beijing China with joint degree from Beijing University and an MBA from Yale University.

Viki Chen, MBA
Regulatory Project Manager, China Med Device 

Vicki Chen has 10 years of experience in China NMPA registration across medical devices, SaMD, and IVD products. She specializes in active and passive devices, cardiovascular technologies, and implantable products. Viki has led cross-region coordination of submission documentation between US/EU manufacturers and China local teams, covering type testing execution and NMPA submission deliverables. She has supported on-site NMPA testing at manufacturers’ sites for capital equipment, including IEC safety and EMC testing activities. Plus, she has experience in China Medical Device GMP-related factory audits/inspection readiness, including QMS documentation review, on-site compliance checks, and pre-inspection preparation support. Viki received her MBA from University of Illinois Urbana-Champaign (UIUC) and her BA from Sichuan University.

Tal Bresler-Stramer
Co-founder, SpringRA

Tal Bresler-Stramer is the founder and principal of SpringRA, a regulatory affairs consultancy that supports the global commercialization of medical devices and AI-based medical technologies. With over 20 years of experience, Tal has contributed to the clearance and launch of a wide range of medical technologies, including hybrid NM/CT scanners and single-use RF treatment tips. For the past eight years, Tal has worked with companies ranging from start-ups to global manufacturers, providing regulatory strategy and support for both immediate submission needs and long-term planning.

In the last five years, Tal’s work has increasingly focused on AI-driven medical technologies, working closely with research and development teams to align technical innovation with regulatory requirements. This work has included the development and successful FDA submission of AI applications such as image reconstruction algorithms, robotic-assisted systems, and computer-guided navigation platforms. Tal has extensive experience with FDA expectations for artificial intelligence, including dataset curation, algorithm validation, and lifecycle change management.

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