The Team Behind Your Regulatory Success
20+ years of hands-on experience. 50+ devices cleared globally. One mission: get your medical device to market — right.
Mita Mistry
Founder & Principal Consultant — Regulatory Frontier
With over 20 years of hands-on experience in medical device regulatory affairs and quality management, Mita Mistry founded Regulatory Frontier with a singular purpose: to make world-class regulatory expertise accessible to the innovators who need it most.
Mita has guided 50+ medical devices through complex regulatory pathways across India, EU, US, and Southeast Asia — ranging from simple Class I devices to high-risk implants and AI-powered SaMD platforms. Her approach is never bureaucratic. It’s strategic, practical, and built around your timeline.
Before founding Regulatory Frontier, Mita held senior RA/QA roles in both multinational MedTech firms and fast-moving startups. That dual perspective shapes everything we do: the rigour of enterprise compliance, delivered with the speed and empathy of a startup partner.
How we work
with you
We don’t parachute in, deliver a binder, and disappear. We embed alongside your team for as long as you need us — week by week, milestone by milestone.
Startup-Friendly from Day One
Month-to-month engagement means you only pay for what you need, when you need it — no retainer lock-ins, no unused hours, no capex burden.
Hands-On Weekly Mentoring
Mita reviews your team’s work every week, catches gaps before they become deficiencies, and keeps every submission on track from submission-ready to approved.
Built Around Your Device
Every roadmap is built from scratch for your specific device class, target market, and risk profile. You get a strategy that fits — not a template that almost fits.
The best medical devices deserve the best shot at reaching patients.
We bring the expertise of a seasoned regulatory team — without the overhead of a full-time hire. Let’s talk about your device.