Dates
This interactive workshop is designed for early-stage medical device founders, operators, and technical leads looking to understand how to incorporate regulatory strategy into early stages of product development to avoid costly redesigns and delays.
Event Logistics:
Time: 10:30 am - 2:30 pm
Format: Interactive workshop with real-world medical device case studies
Networking Lunch: Refreshments and snacks provided!
What You Will Learn:
Participants will be introduced to core FDA regulatory concepts, including device classification, pathways to market (510(k), De Novo, PMA), and how regulatory decisions influence testing, evidence generation, and commercialization timelines. The session also covers Health Canada considerations and when a U.S. vs. Canada-first strategy may make sense. Attendees will also engage with hands-on case studies and interactive breakout sessions, applying regulatory frameworks to real-world medical devices that have navigated the path to market.
Who Should Attend:
Medical device startups, clinical founders, engineers, and product teams preparing for pre-clinical development, early validation, or future regulatory submissions.
Workshop Facilitator: Liz Munro, Founder and Principal Consultant, LMC Inc.
Liz is a medical device development and regulatory expert with 15+ years of experience in innovative medical technology business. Currently, she acts as a fractional executive and product development and regulatory advisor to a small number of MedTech startups. Liz was also the co-founder of Perimeter Medical Imaging AI, where she built the medical device development program from the ground up—securing four FDA clearances and Breakthrough Device Designation, executing clinical studies involving more than 400 patients, and raising nearly $40M in capital.
Parking:
Free parking will be available at the Convergence Centre during the event.
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