Deepthi P.

About Deepthi P.

Views are my own and do not represent my employer.I believe the best regulatory and compliance strategy doesn’t slow innovation down. It’s what makes sustainable innovation possible. My track record is proof that you can have innovation, speed, and compliance work in harmony. With a DDS from the University of Michigan and an MS in Regulatory Science from Johns Hopkins, I’ve spent my career at the intersection of clinical practice, clinical affairs, AI/ML enabled medical devices, and global regulatory affairs. I specialize in AI/ML-enabled medical devices, and I’ve led end-to-end regulatory strategy and clinical validation for FDA 510(k) clearances and global regulatory approvals (K231678, K233590, K233738, K241681, K241684, K250755, K253009), with additional contributions to K212519, K220928, and K253959.What I’ve learned doing this work is that compliance done well doesn’t create friction. It creates confidence. It gives development teams a clear path forward, gives clinical stakeholders something they can trust, and gives regulators what they need to say yes.I work closely with engineering, marketing, clinical, and product teams to build strategies that are proactive rather than reactive, and that treat compliance as a foundation for speed rather than a barrier to it.Outside of that, I’m passionate about advancing the field more broadly, whether that’s through AI governance frameworks, regulatory and clinical affairs leadership, or helping organizations understand what it actually takes to bring safe, effective AI to patients.

Experience

1. Senior Manager Regulatory Affairs-cts Ai Samd

   Dentsply Sirona

   Sep 2024 — Present

   Leading regulatory strategy and market access for AI-enabled SaMD and connected technology devices at a global medical device company.Secured 3 FDA 510(k) clearances for novel products in my first 18 months (K250755, K253009, K253959), establishing groundwork for global market access. Achieved CE marking for multiple AI-enabled devices & cloud connected imaging device platforms under EU MDR.

Education

• University of Illinois Chicago

  Bachelor of Science - BS, Biology, General

• University of Michigan

  Doctor of Dental Surgery-DDS, Dentistry

• The Johns Hopkins University

  Master of Science - MS, Regulatory Science