One device.
Every market that matters.
Regalis guides medical device manufacturers through the regulatory pathway to market — in the United States, Europe, and India — and to the quality certifications the world asks for.
Regulatory pathways for medical devices
Whether you're entering your first market or your fourth, Regalis manages the strategy, the documentation, and the submission — so your device reaches patients without the regulatory guesswork.
FDA
Market clearance for the U.S. — from choosing the right pathway to a submission that's ready for review.
- 510(k) premarket notification & eSTAR preparation
- Product code, predicate & substantial-equivalence strategy
- Small Business Determination for reduced FDA fees
- Intended use, labeling & U.S. Agent guidance
CE Marking
Conformity under the EU Medical Device Regulation, structured for a smooth Notified Body assessment.
- Technical documentation to MDR Annex II & III
- Classification & conformity assessment routing
- General Safety & Performance Requirements (GSPR)
- EU Authorised Representative & Notified Body liaison
CDSCO
Import, manufacturing and registration approvals for the Indian market, filed through the CDSCO portal.
- Device classification (Class A / B / C / D)
- Import licence (MD-14 / MD-15) applications
- Manufacturing licence (MD-5 / MD-9) support
- Registration & dossier preparation on SUGAM
Certifications
The quality systems and consensus standards that underpin every market submission you'll make.
- ISO 13485 quality management system build & readiness
- ISO 14971 risk management files
- IEC 60601 & standards gap analysis
- Audit preparation & certification support
A clear path from device to decision
Regulatory submissions stall on the things that are missing. We map the whole route first, so nothing surfaces late.
Assess
We confirm the device's classification, target markets, and the right pathway — and flag the gaps before you spend on the wrong one.
Plan
A submission plan with predicate or conformity strategy, required testing, and a realistic timeline and cost for each market.
Prepare
We build the dossier — technical documentation, labeling, risk files — structured the way the reviewer expects to read it.
Submit & support
We file, then manage clarifications and deficiency responses through to the authority's decision.
Built for manufacturers who'd rather build.
You know your device. We know the pathway. Regalis exists so regulatory strategy accelerates your launch instead of holding it hostage.
One team, four jurisdictions
FDA, CE, CDSCO and ISO under a single engagement — so your submissions stay consistent and you brief one partner, not four.
Documentation that survives review
We prepare dossiers to what each authority actually expects, reducing the deficiency rounds that stretch timelines by months.
The cheaper route, when there is one
From small-business fee reductions to bundling strategy, we look for the path that protects your budget — especially for early-stage teams.
Regulatory specialists for the medical device industry.
Regalis Consulting LLP is an independent medical device regulatory consultancy. We help manufacturers — from first-time startups to established makers expanding abroad — take their devices through the approvals that open each market.
Our work spans the full lifecycle of a submission: pathway strategy, technical documentation, quality systems, and the back-and-forth with regulators that gets a device cleared. We stay deliberately focused on regulatory affairs, so the depth is real.
Regalis brings together regulatory, quality, technical and clinical specialists across the four markets we serve — so whatever your device and wherever it's headed, the right expertise is on it.
Tell us about your device.
Share the device, the markets you're targeting, and where you are today. We'll come back with the pathway and a clear next step.