Health Tech Regulation: Essential knowledge for success in health tech.
You’ve thought up a fantastic idea. You build the prototype, and it works! Next you want to start selling it to patients (or healthcare facilities) but then someone asks whether the product is licensed.
By then, decisions made early on have already set how much evidence, time and money stand between the product and its first patient. Did you note down when versions changed? Are you sure you're NOT a medical device? Are you ISO 13485 compliant (whats that??). At worst, you might end up on the wrong side of the law before you’re even off the ground.
This panel brings together Karim Keshavjee, Program Director of the Master of Health Informatics at the University of Toronto; Thomas Moore, founder of PTL Solutions, who takes startups through Health Canada, US Food and Drug Administration (FDA) and European Union approvals; and Mia Spiegelman, who leads regulatory affairs at Medtech Canada, the national medtech industry association. They will work through real product examples, from a wellness app to an AI diagnostic tool, and show where each one ends up under the rules and why.
WHY ATTEND
You’ll leave knowing:
• How to tell early whether your product counts as a medical device, which class it falls into, and what that means for your timeline.
• What regulators expect to see, including evidence, a quality management system and documentation, and when to start building it.
• How the rules for AI-enabled tools are changing in Canada, and where founders can get help.
IDEAL FOR
• Founders and builders developing digital health, AI or device products.
• Clinicians and health-system staff who bring new tools into care.
• Graduate students and researchers planning to commercialise their work.
• Investors and policy people tracking Canadian health tech.
PROGRAM OUTLINE
Date: Wednesday, November 25, 2026
Location: University of Toronto – Grad Loft Room, 16 Bancroft Avenue, Second Floor
Free entry. Pizza available on the night for [$5, cash only].
6:00 to 6:15 PM: Check-in and networking
6:15 to 6:20 PM: Opening remarks
6:20 to 7:00 PM: Moderated panel discussion
7:00 to 7:20 PM: Audience Q&A
7:20 to 8:30 PM: Networking and close
Panelists:
Karim Keshavjee, MD is Program Director of the Master of Health Informatics at the University of Toronto and a family physician by training. He has 25 years in primary care health IT, including Canada Health Infoway’s e-prescribing standards, and co-authored a 2025 paper on how Canada regulates health tech.
Thomas Moore, PhD founded PTL Solutions, a Montreal medical device consultancy. He has about 20 years helping companies through Health Canada, US Food and Drug Administration (FDA) and European Union approvals, and he mentors founders at the University of Toronto’s Health Innovation Hub.
Mia Spiegelman is Vice-President, Regulatory, Quality and Environmental Affairs at Medtech Canada, the national medtech industry association. She has more than 20 years in regulatory affairs, leads the association’s regulatory work for its member companies, and has testified to a House of Commons committee.
Moderator:
Dr.James Kurrle is a medical doctor and the founder of Aescia, a health tech company that guides patients before and after procedures.