

CIP Impact Dining Series: From Concept to Compliance: Navigating FDA Pathways from Day One
From Concept to Compliance: Navigating FDA Pathways from Day One
📅 July 1, 2025 | 🕠 5:30 PM – 8:00 PM
📍 Cambridge, MA (Venue Shared Upon Confirmation)
🍽️ 10-Course Private Dinner | 🧠 Peer Roundtable | 🗣️ Expert Dialogue
💡 Event Overview
Whether you're just beginning to explore regulatory requirements or are gearing up for your first FDA Pre-Submission meeting, this private dinner is for you. We’ll walk through key steps from early planning to actual FDA engagement—giving innovators at every stage a clearer view of what it takes to build a fundable, credible regulatory strategy.
You’ll learn:
• What early-stage founders should know about FDA pathways (even before Pre-Sub)
• How to frame your regulatory approach for partners and investors
• What happens at your first FDA meeting—and how to prepare for it
• Common pitfalls and ways to de-risk your early decisions
👥 Who Should Attend
• Early-stage medtech and digital health founders seeking regulatory clarity
• Founders raising capital who need to align on a compliance story
• Regulatory, R&D, or strategy leads working toward FDA interaction
• Advisors and investors supporting product development in regulated spaces
📌 What to Bring (or Submit in Advance)
To help guide the conversation, we encourage you to bring:
• Questions about FDA timelines, documentation, or pathways
• Specific challenges you’re facing in your go-to-market strategy
You may also submit questions during registration. This is not a lecture—it’s a peer-participated, expert-guided conversation.
🌟 Why This Dinner is Different
🔹 Exclusive Group, Meaningful Access – Limited to 10 thoughtfully selected guests
🔹 Relaxed Atmosphere, Strategic Focus , No panels or pitches, just real conversation
🔹 Premium Experience, Enjoy a 10-course Chinese meal in a w well-known restaurant within Cambridge’s innovation corridor
🌱 New Ticket Category: Founders Pass (No Cost)
We’re offering a limited number of Founders Passes at no charge for qualified early-stage medical device and digital health entrepreneurs who are actively navigating regulatory planning. Apply now to join the conversation—free of cost but full of value.
🎟 How to Join
•Apply early Only – Max 12 guests
• Applications reviewed on a rolling basis
• Final venue details shared upon confirmation
Once approved, please block your calendar. Seating is limited and important—register only if you can commit.
🔗 About the Host: Cambridge Innovation Partners (CIP)
Cambridge Innovation Partners is a boutique connector and curator of impact-driven gatherings. CIP fosters meaningful relationships by bringing together founders, experts, and strategic partners across biotech, medtech, and emerging technology. We believe collaboration grows through shared insight, trust, and thoughtful exchange.
📸 Photo/Media Disclaimer
Photos or video may be captured during the event. By attending, you grant permission for use in future outreach and documentation.r use in future outreach and documentation.