​Bringing a health tech product to market requires more than a great product, it requires a clear understanding of the regulatory landscape from the very beginning.

​Whether you’re developing a medical device, digital health solution, software as a medical device (SaMD), or combination product, early regulatory decisions can significantly influence your product design, development timeline, funding strategy, and commercialization success.

​Join Dr. Thomas Moore, Founder and General Manager of PTL Solutions, for a practical workshop designed specifically for early-stage health technology companies. Drawing on more than 20 years of experience supporting innovators through FDA, Health Canada, and international regulatory pathways, Thomas will share actionable guidance to help founders avoid common pitfalls and build a regulatory strategy that supports long-term growth.

​What You’ll Learn
​Understand the role of Health Canada, the FDA, and other regulatory agencies in bringing health technologies to market.

​Determine your product’s intended use, risk classification, and regulatory pathway.

​Learn the differences between 510(k), De Novo, and other regulatory submission pathways.

​Explore global regulatory considerations for companies planning international expansion.

​Develop a proactive regulatory strategy that aligns product development, investment readiness, and commercialization goals.

​Whether you’re still validating your concept or preparing for regulatory submission, this session will provide the foundational knowledge needed to make informed decisions and reduce risk as you scale.

This event is not affiliated with Invest Ottawa and is independently organized by a third party.