Transform your regulatory workflows from time-consuming manual searches to strategic, data-driven decision-making. This interactive three-hour workshop demonstrates how AI-powered tools are revolutionizing medical device regulatory processes, turning decades of fragmented data into actionable insights.
At this virtual event, expert speakers will lead you through:
- Real case studies showing $300K cost savings, accelerated FDA approvals, and streamlined predicate searches
- Live demonstrations of AI tools for regulatory database analysis, adverse event trending, and precedent research
- Hands-on practice with scenarios relevant to your daily challenges
- Implementation roadmap to integrate AI solutions into your existing workflows
You will leave this workshop with a list of tools you can start to implement right away.
Registration Fees & Deadlines
Present – 03 May 2026: Early Bird Member $300 | Nonmember $350
04 May 2026 – 03 June 2026: Regular Member $350 | Nonmember $415
Learning Objectives
At the conclusion of this workshop, participants should be able to:
- Identify specific AI applications that address their current regulatory challenges
- Evaluate the ROI potential of AI-powered regulatory tools
- Develop an implementation strategy for their organization
Who Should Attend?
Medical Device professionals who are interested in:
- Regulatory Intelligence/Strategy/Policy
- Regulatory writing/documentation
- Post Market Surveillance/Risk Management
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
Who is the intended audience?
Medical Device professionals who are interested in:
- Regulatory Intelligence/Strategy/Policy
- Regulatory writing/documentation
- Post Market Surveillance/Risk Management
Agenda
|
Time
|
Topic
|
|
10:00 AM – 10:05 AM
|
Introduction (5 min)
- Welcome and introductions
- Workshop goals, expected outcomes, and how to participate (Q&A, Zoom functions, etc.)
|
|
10:05 – 10:50 AM
|
Session 1:
- Practical use cases and examples from first-hand experience of working with hundreds of users in regulatory strategy, regulatory consulting, and intelligence
Lauren Naficy
|
|
10:50 – 11:05 AM
|
Session 1 Questions and Answers
|
|
11:05 – 11:10 AM
|
Break
|
|
11:10 AM – 11:55 PM
|
Session 2
- A practitioner’s journey as an experienced regulatory professional, how to evaluate, learn, and implement AI tools in day-to-day work
- Strategic guidance in a startup context: speed with confidence
- Pre-Sub preparation: comparison of similar products, requirements, standards, informed Qsub, and meaningful discussion
- Risk management: analysis of similar products to guide the probability of occurrence for hazardous situations in novel products
- Post-market surveillance: adverse event trending, recalls, and signal detection
- Teaching perspective at USCS Silicon Valley Extension
Leena Kadakia
|
|
11:55 – 12:10 PM
|
Session 2 Questions and Answers
|
|
12:10 – 12:15 PM
|
Break
|
|
12:15 – 12:45 PM
|
Session 3
- The "Big Three" Snapshot: Compare ChatGPT, Gemini, and Copilot, and learn how to choose the right tool for the right regulatory tasks.
- 10-Minute Adoption Audit: A quick framework to validate if a tool adds value or unnecessary risk. Avoid the trap of “Using AI for the Sake of Using AI”.
- Augment, Don’t Replace: Enhance expert judgment in RA/QA, avoid brain rot.
Michelle Wu
|
| 12:45 – 1:00 PM |
Final Q&A, wrap-up, and next steps (15 min)
|
Speakers
Michelle Wu is the founder and CEO of NyquistAI. She has over a decade of experience in pharmaceuticals, medical technology, and digital innovation. She has been recognized as the Top 100 Women in AI in 2025, featured by Forbes, and given talks on AI in life science in various conferences. She is a book chapter author for AI in Healthcare by MIT Press.
Before founding NyquistAI, she was the youngest global strategy manager at Novartis AG, where she worked on the very first and so far the only asset swap deal in the history of the pharmaceutical industry among Novartis, Eli Lilly, and GSK, which led her to realize the universal pain point of manual and cumbersome data research and potential pitfalls if it is not done right. This experience inspired her to build NyquistAI. Prior to Novartis, she worked for the life science practice for BCG and served big innovative pharmaceutical and Medtech companies on their global strategy, product development strategy, and emerging market strategies. She received her MBA from Stanford University and BA from Peking University.
Lauren Naficy
Director of Client Success, NyquistAI
Lauren Naficy brings over a decade of expertise in training life sciences professionals to adopt and leverage new tools and technologies. She currently serves as director of client success at NyquistAI, where she partners with organizations of all sizes to integrate cutting-edge AI solutions into their workflows. Her role emphasizes guiding clients through successful adoption strategies, ensuring measurable outcomes, and fostering long-term relationships built on trust and innovation. Lauren holds a bachelor’s degree in cellular biology from the University of California, Santa Barbara. She currently resides in Portland, Oregon, where she enjoys life with her husband, toddler, and cat.
Leena Kadakia, MS, RAC
VP Regulatory Affairs, RefleXion Medical; Regulatory & Quality Consultant
Leena Kadakia is a seasoned regulatory and quality affairs executive with more than 20 years of experience advancing innovative medical technologies from concept through global commercialization. She uses strategic regulatory insight and technical rigor to guide organizations through high-stakes decision-making in fast-moving clinical and engineering environments. Leena’s expertise spans global regulatory strategy, FDA submissions across 510(k), IDE, and De Novo pathways, compliance, design controls, verification and validation, risk management, and clinical affairs. Leena holds a bachelor’s degree in chemical engineering from the Massachusetts Institute of Technology and a master’s degree in biomedical engineering from Johns Hopkins University. She holds aRAC-US credential and is an instructor at UCSC Silicon Valley Extension in the Regulatory Affairs department.
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.