Validated AI Conference - Ketryx
Validated AI Conference — Cambridge, MA
Join us for a free half-day conference focused on validating AI in regulated environments. Request an invite to attend in person in Cambridge or join virtually from anywhere. You'll learn how leading teams are integrating AI into products and development processes without sacrificing compliance or speed through expert-led sessions and candid peer discussions. Hear from experts, connect with peers, and be part of a community working to bring safe, effective AI to patients faster.
Industry Leaders Attending
What's in Store?
Insights and strategies to accelerate AI adoption in regulated industries
Compliance Frameworks for AI Systems
Discover validation frameworks for AI systems in regulated environments. Learn how to implement FDA guidance on AI/ML validation, create audit-ready documentation for AI, and maintain end-to-end traceability.
Pilot to Production: Real AI Validation Journeys
Hear real-world case studies of how companies validated AI in production under IEC 62304 and ISO 14971. Learn documentation strategies that passed audits, governance frameworks that worked, and honest lessons learned from pilot to production.
Validating AI Workflows in Practice
Learn practical frameworks for validating AI in regulated workflows—from automated testing to change impact analysis. Explore how to implement human-in-the-loop controls, build audit trails that satisfy FDA requirements, and incorporate AI in regulated environments.
Venue
The Engine is a venture firm built by MIT that invests in founders solving the world's toughest problems through breakthrough science and engineering.
The Engine by MIT · 750 Main St, Cambridge, MA 02139
Agenda
An afternoon of expert insights, hands-on learning, and meaningful connections.
- 12:00 – 12:45 PM
Registration & Networking
Check in and connect with fellow attendees.
- 12:45 – 1:05 PM
Building Safety-Critical AI
Doctors are diagnosing with AI, autonomous vehicles are navigating city streets, and labs are compressing months of experiments into days. This isn't a vision of where things are headed. This transition is happening right now, all over the world. This session explains what validated AI is making possible, and how to take a risk-based approach to building safety-critical AI systems.
Erez Kaminski
- 1:05 – 2:00 PM
AI Adoption in Life Sciences: What's Working
The question is no longer whether to adopt AI. It's how companies are putting it to work in practice. This session explores how life sciences organizations are deploying AI across imaging, patient monitoring, clinical development, and commercial functions, what's driving adoption, and what it takes to operationalize these initiatives at scale.
Scott Rosen
Mike Monovoukas
Erez Kaminski
- 2:10 – 2:45 PM
Accelerating AI-Native Product Development
AI coding tools like Claude Code and Cursor are already in your engineers' hands. This session covers what changes when AI is writing production code and hardware in a regulated environment: how code review practices need to evolve, where CI/CD needs guardrails, and how quality teams need to operate when the way software gets built has fundamentally changed.
Gabriel Pascualy
Don O'Neill
Prachee Chaturvedi
- 2:45 – 3:20 PM
AI Maturity Across the SDLC: From Design to Deployment
AI is now a standard part of how software is built, but in regulated environments, every change still needs to be understood, validated, and tied to intended use. This session explores how teams progress along an AI maturity curve, from deterministic processes to AI-assisted development, and how they accelerate from a mature foundation without losing control. You'll hear how leading teams connect risk, requirements, and validation as change becomes continuous, so they can move faster while staying audit-ready.
Jenn Dixon
Joy Foster
- 3:20 – 3:45 PM
Networking Break
Recharge and connect with fellow attendees.
- 3:45 – 4:20 PM
Making AI Work in Life Science
AI is managing batch records, flagging deviations, and monitoring processes in real time. This session explains what AI actually looks like inside GxP operations right now, what it takes to get there, and what the industry can learn from organizations that have already made the leap from concept to compliant deployment.
Michelle Vuolo
Behnam Partopour
Tim Brodeur
- 4:20 – 5:00 PM
Getting AI Past the Pilot
Whether it's compliant handling, change impact assessment, or regulatory document generation, the gap between proof of concept and production is familiar to anyone trying to accelerate AI adoption in their organization. This session offers advice to close that gap, showing what it takes to build coalitions, make the case, and create the conditions where AI becomes how work gets done.
Norm Lord
Rajesh Misra
Varun Ramdevan
Mary Brook Delano
- 5:00 – 5:15 PM
Closing Remarks
Erez Kaminski
- 5:15 – 6:15 PM
Cocktail Hour & Networking
Wind down with drinks, bites, and meaningful conversations.
Speakers
Insights from leaders accelerating innovation at high growth companies and Fortune 50 enterprises
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Erez Kaminski
Former Head of AI
Amgen
Now Founder & CEO, Ketryx
Michael Monovoukas
Co-Founder & CEO
AcuityMD
Michelle Vuolo
Head of Quality
Tulip
Rajesh Misra
Principal Life Sciences Quality and Regulatory
KPMG
Jenn Dixon
Former Director of QA/RA
Omniscient Neurotechnology
Now Director of AI Quality & Regulatory Strategy, Ketryx
Don O'Neill
Vice President of Engineering
Sequel Med Tech
Mary Brook Delano
Former Senior VP Life Sciences
Definitive Healthcare
Now Chief Business Officer, Ketryx
Varun Ramdevan
External Innovation and Partnerships, Enterprise Technology
Johnson & Johnson
Scott Rosen
Partner
Transformation Capital
Norm Lord
Vice President, Digital Products
Revvity
Prachee Chaturvedi
Director, Digital & AI Product R&D
Sanofi
Behnam Partopour
Principal Scientist
Sartorius
Joy Foster
Head of the Lab and Clinical Engineering Platform
GeneDx
Gabriel Pascualy
Former Principal Investigator
MITRE
Now Head of Product, Ketryx
Tim Brodeur
Former VP of Customer Success
Causaly
Now VP Success & Delivery, Ketryx
Meet Your Moderator
Join us for an evening with Erez Kaminski, who advises three of the top five medical device companies and brings deep expertise in regulated AI development and a passion for improving patient outcomes.
Erez Kaminski
CEO & Founder • Ketryx
Former Head of AI, Amgen
Watch On Demand
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The next Validated AI conference is Thursday, October 1, 2026. Sign up to be the first to know when registration opens.
Presented by
Ketryx transforms the product lifecycle of life science teams to deliver safer products, faster. Trusted by four of the world's top five medical device manufacturers, its AI-powered compliance platform overlays existing tools to automate documentation, create traceability, and accelerate release cycles—without disrupting existing workflows. Ketryx AI Agents cut manual work by 90 percent and close compliance gaps, elevating speed and quality across the entire product lifecycle. For more information, visit www.ketryx.com.