With just one week until AdvaMed’s Online Medical Device Submissions Workshop Series begins, February 23–27, I wanted to share why I continue to participate in these Workshops and why it remains one of the most valuable learning opportunities for medtech regulatory teams.
Why this Series Matters
In regulatory affairs, success comes down to preparation, organization, and practical experience. Over the course of my career, I’ve seen firsthand how a well-planned submission and early alignment with FDA can make a meaningful difference — not only in review timelines, but in overall outcomes for patients and organizations alike. That’s the focus of this series – helping teams move from understanding regulations to applying them in real-time with confidence.
Built Around Real-World Submissions
These workshops are designed around what regulatory teams actually need to execute strong submissions. Rather than high-level theory, sessions center on practical decision-making, common challenges, and proven approaches across the submission lifecycle.
Across the series, we’ll cover:
- 510(k) & De Novo strategies and submission planning
Earn up to 12 RAC credits - IDE fundamentals for clinical study readiness
Earn up to 6 RAC credits - PMA approaches for managing complex evidence and review expectations
Earn up to 12 RAC credits
Each program is grounded in examples, current FDA expectations, and open discussion to give attendees strategies they can apply to active and upcoming submissions.
What I’ll Share
I’ll be participating across the 510(k) & De Novo, IDE, and PMA workshops, leading sessions that focus on:
- Developing a clear and effective IDE strategy
- Maintaining compliance throughout clinical studies
- Preparing for productive FDA interactions
- Working through real-world PMA challenges in an open forum setting
My goal is to share practical lessons on what works and what doesn’t so teams can better position their submissions from the start.
Ask Questions and Leave More Prepared
These workshops are hands-on, discussion-driven, and led by FDA reviewers and industry professionals who navigate these pathways every day. They provide a valuable opportunity to ask questions, compare approaches, and walk away with greater confidence in your next submission.
If you’re preparing for a submission this year or looking to sharpen your regulatory strategy, I hope you’ll join me next week!
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