Your medical device deserves
to reach the market — without the delays.
We guide medical device manufacturers through USFDA 510(k), CDSCO MDR, and EU MDR approval — from strategy to submission. No guesswork. No rejected applications.
End-to-end regulatory consulting
for serious MedTech companies
We don't teach theory. We do the work — building your submission, fixing your QMS, and navigating regulators on your behalf.
USFDA 510(k) Submission Support
Full-service 510(k) preparation for Indian manufacturers entering the US market. We handle strategy, predicate selection, technical file, and eSTAR submission.
- Device classification & predicate research
- Substantial equivalence argument
- Performance testing strategy
- Complete 510(k) dossier preparation
- FDA query response support
CDSCO MDR 2017 Registration
Complete CDSCO registration support for domestic manufacturers and foreign companies entering the Indian market. Class A through D devices.
- Device classification under MDR 2017
- Manufacturing / import license applications
- Technical documentation preparation
- SUGAM portal submission & follow-up
- Post-market compliance support
ISO 13485 QMS Implementation
We build your Quality Management System from scratch — documentation, SOPs, training records, and audit readiness. Built to pass, not just exist on paper.
- Gap analysis against ISO 13485:2016
- Full quality manual & procedure library
- Internal audit programme setup
- Staff training & competency records
- Certification body audit support
EU MDR Technical Documentation
CE marking under EU MDR 2017/745. We prepare your technical file, clinical evaluation report, and notified body submission — built to Annex II & III standards.
- MDR classification & route assessment
- Annex II technical documentation
- Clinical evaluation report (CER)
- Post-market surveillance plan
- Notified body liaison support
Annual Compliance Retainer
Retain us as your regulatory affairs team — on call for queries, handling license renewals, PMS reporting, adverse events, and keeping you audit-ready year-round.
- Dedicated regulatory consultant
- License renewal management
- Adverse event & vigilance reporting
- Regulatory change monitoring
- Unlimited email & call support
Corporate Regulatory Training
Bespoke on-site or virtual training workshops for QA, RA, and R&D teams. Tailored to your product portfolio, target markets, and team competency gaps.
- Needs assessment & training design
- Half-day to 3-day workshop formats
- USFDA, EU MDR, CDSCO, ISO 13485
- Certified completion records
- Post-training competency assessment
From first call to market approval
A structured, transparent engagement — so you always know where you stand and what comes next.
Free discovery call
30 minutes. We listen, assess your device and target market, and tell you exactly what's needed — no obligation.
Regulatory roadmap
We map out the full regulatory pathway: classification, timeline, documentation checklist, and estimated costs.
Documentation & submission
Our team prepares every document, handles submissions, and tracks your application with the authority.
Approval & beyond
We support you through queries, deficiency responses, and post-approval compliance — until your device is on the market.
Built for companies that are serious about approval
We work best with companies that have a device ready — and need a partner to navigate the regulatory path efficiently.
Indian manufacturers exporting to the US
You have a product ready and want FDA clearance to sell in the American market. We've done this before.
MedTech startups and founders
You're building a new device and need to understand the regulatory path early — before it becomes expensive.
Foreign companies entering India
Global brands and importers needing CDSCO registration, import licenses, and local compliance management.
Established manufacturers going global
You're in one market and want to expand to the US, EU, or other regulated markets. We handle the multi-market strategy.
Companies that received a rejection or deficiency
If CDSCO or FDA has asked questions or rejected your application, we step in and fix it.
QA teams preparing for audits
Your team needs hands-on training and gap analysis before a CDSCO inspection or ISO certification audit.
Trusted by professionals across the globe
"The 510(k) guidance was exceptional — detailed, practical, and exactly what we needed to move forward with our US submission confidently."
"NextGen completely transformed our FDA audit readiness. Their understanding of 21 CFR Part 820 is genuinely industry-level — not textbook."
"I was lost with CDSCO registration. After working with NextGen, our Class B device was registered in 7 months. Clear guidance the whole way."
Let's get your device
approved.
Book a free 30-minute consultation. We'll assess your device, your target market, and give you a clear next step — no pressure, no obligations.