Your Medical Device’s Path
to Global Markets Starts Here
Your Medical Device’s Path
to Global Markets Starts Here
From prototype to global clearance — we guide medical device startups through CDSCO, EU MDR, ISO 13485 & US FDA. Month-to-month. No lock-ins.
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What Makes Us Different
We combine decades of hands-on regulatory experience with a personalised approach — so your device clears faster, with confidence.
Hands-On, Week-by-Week Guidance
We don’t hand over templates and disappear. We sit with your team, review their work, and guide every submission milestone from start to approval.
Tailored for Your Device & Market
Your device isn’t generic — neither is our approach. Whether it’s an implant, IVD, or digital health tool, we build the regulatory strategy around your specific product and target markets.
Premium Expertise at Startup-Friendly Rates
Get the same quality of regulatory guidance that large MedTech companies pay lakhs for — at pricing structured for startups and growing teams.
20+ Years. 50+ Devices. 15+ Markets.
From India’s CDSCO to EU MDR, US FDA, and Southeast Asia — Mita Mistry brings deep multi-market experience that most consultants simply don’t have.
Who We Work With
Every stage.
Every device type.
One partner.
We don’t work with everyone — we work with the right people. Whether you’re sketching your first device or scaling across continents, we bring the same depth of regulatory expertise to the table.
Medical Device Startups
You’re moving fast with a lean team and no room for regulatory surprises. We become your on-demand regulatory department — handling CDSCO, FDA, and CE submissions so you can focus on building the product.
Pre-Seed → Series B · CDSCO · FDA · CE MarkEstablished Manufacturers
You have an existing portfolio but new markets, updated standards, or post-market obligations are stretching your internal team. We plug in precisely where the gaps are — without the overhead of a full hire.
ISO 13485 · EU MDR · Post-Market SurveillanceSoftware & AI Medtech
SaMD classification, IEC 62304 documentation, and evolving AI/ML guidance make software submissions uniquely complex. We’ve navigated this landscape across multiple jurisdictions and know exactly what regulators look for.
SaMD · IEC 62304 · AI/ML Guidance · Risk Management
Regulatory Frontier is where precision meets pace. We help innovative medical device companies move from idea to clearance without losing speed — because the world’s patients can’t wait for great technology to arrive.
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