A-MEDICO Webinar Series: Practical Strategies for Navigating Regulatory Pathways for Health Innovation

​Demystify your regulatory pathway with this essential session – learn to build your regulatory plan yourself:

• ​Understand the role of regulatory agencies like FDA and Health Canada in ensuring product safety and efficacy.

• ​How to 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.

​​​Speaker:
Thomas Moore, PhD, Founder and General Manager of PTL Solutions, Inc.

​​​Speaker’s Bio:
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 20 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 consultants—each bringing 15–25 years of hands-on expertise. The firm supports startups and established manufacturers alike with hardware and software development, clinical testing, and usability engineering. Under Thomas’s leadership, and with a highly skilled and experienced cross-functional team, PTL Solutions streamlines each client’s journey from concept to commercialization.