Navigating Regulatory Pathways for Health Innovation
Thursday, September 10, 2026, 10:00 AM PDT – 12:00 PM PDT
10918 Technology Pl, San Diego, CA 92127, USA
Hosted by Aquillius
Demystify your regulatory pathway with this essential session: Understand the role of regulatory agencies like FDA and Health Canada in ensuring product safety and efficacy. Define your solution’s classification and intended use to chart a clear regulatory pathway. Learn strategies for leveraging predicate devices and exploring 510(k) and De Novo submissions. Navigate global market entry requirements and compliance frameworks. Develop a proactive regulatory strategy to minimize barriers and align with business goals.
Speakers
Thomas Moore, PhD
Founder/General Manager at PTL Solutions
Thomas Moore, PhD is the Founder and General Manager of PTL Solutions Inc., a Montreal-based consulting firm that helps medical device and combination product companies accelerate development and achieve regulatory and quality compliance efficiently. With over 21 years of experience in the medical device industry, Thomas has led projects spanning regulatory strategy, quality management, product development, and market access under FDA, Health Canada, and EU frameworks. PTL Solutions was created with a clear mission: to deliver exceptional value by engaging only highly experienced…