Navigating the Regulatory Maze: From Prototype to Market Approval
Most medtech founders are brilliant technologists, but most have little experience working in regulated environments. From our voice-of-customer interviews, the pattern is consistent: they aren't sure what to do, when to do it, or how it's done, so they push ahead and discover the consequences too late, whether that's the wrong regulatory pathway, a claim no one wants, or a quality system built at the wrong moment. Each costs time and money they can't afford.
Join PTL Solutions for a practical crash course in medical device regulation for founders We will cover regulatory strategy versus regulatory assignment, why iteration beats the waterfall model, how to keep a quality system lean, and what FDA citation data reveals about where companies fail. The focus throughout is on tips, tricks, and best practices you can apply immediately.
Attendees will leave being able to:
Distinguish a regulatory strategy from a regulatory assignment, and understand how pathway decisions ripple through the rest of the business
Recognize why development is iterative, not a waterfall, and where regulatory, clinical, user needs, and quality fit into that loop
Time their quality management system correctly, avoiding both the too-early and too-late traps, and keep it lean
Understand what FDA citation data reveals about where companies actually fail
Know when to bring in expertise, and what happens to founders who don't
Whether you are early enough to be unsure what regulatory work needs to happen, when it needs to happen, and how it gets done, or far enough along to want a second opinion on the pathway, claims, and quality system you have already committed to, this session delivers practical tips and tricks from a team of consultants with 15 to 25 years of hands-on experience each, so early-stage founders can avoid expensive missteps and later-stage teams can catch them before they become expensive.
SPEAKER:
Thomas Moore, General Manager @ PTL Solutions Inc.