Startup School: Regulatory Pathways with UVM Innovations

Startup School: Regulatory Pathways

Hosted by UVM Innovations

Please join us on November 6th for our upcoming session of Startup School, part of our Innovation Improv series, designed to help guide graduate students, postdocs, and faculty through the first steps of bringing a technology to market.

Event Details

Startup School: Session 2 – Regulatory Pathways

📅 Thursday, November 6, 2025

🕘 1 PM – 4:30 PM

📍 Room 129, Patrick Leahy Building, UVM Main Campus (105 Carrigan Drive

Burlington, VT 05405)

This month, we will dive into regulatory pathways with a focus on medical devices. Join us in Leahy 129 from 1–3 PM to hear from industry expert Thomas Moore, PhD, with over 20 years of experience in Medical Device Consulting. From 3–4:30 PM, participants will have the opportunity for an open Q&A session with Thomas to discuss their own ventures and ideas.

RSVP now and reach out to innovatenews@uvm.edu with any questions.

We hope to see you there!

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About Thomas Moore, PhD:

Thomas has worked in the Medical Device Industry for over 20 years. He has extensive experience leading medical device and combination product projects that are compliant with HC, FDA and EU regulations and standards. He is the General Manager of PTL Solutions Inc., a consulting company that uses very experienced professionals to provide regulatory affairs, quality management, product development and go-to-market support to medical device manufacturers and pharmaceutical companies of all sizes. From PTL’s inception, it was important to Thomas that only very experienced experts consult for PTL customers ensuring high-quality advice and guidance. Throughout Thomas’s career, he has demonstrated a strength in assessing company strategies across regulatory, quality, product development, and go-to-market, and has helped provide guidance to reduce time and cost to get to market while also ensuring project success. Thomas has significant experience assessing and ensuring the timely implementation of Quality Management Systems (QMS) processes and the creation of accompanying documentation. Thomas has also advised several medical device manufacturers around developing proper regulatory strategies, communications and submissions, leading product development projects, and developing both upstream and downstream go-to-market strategies and overseeing their implementation. Thomas isn’t afraid to say “I don’t know” and has surrounded himself with a wide-range of experts much smarter than him to ensure all of PTL’s customers needs are met.

Navigating Regulatory Pathways for Health Innovation

· 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.

Fundamentals of Quality Management Systems (QMS) in Health Tech

· Lay the groundwork for regulatory success with practical insights into quality management:

· Learn the core components of a QMS, from document control to risk management.

· Differentiate between QMS that meet early-stage needs and full QMS implementation for scaling.

· Tailor your system to meet international standards and device-specific requirements.

· Discover tools and best practices for managing quality processes efficiently.

· Foster a culture of quality to streamline compliance and drive long-term success.