Medical Devices
Class A–D devices across cardiology, ortho, neuro, imaging, and surgical equipment. From single-component disposables to active implants.
We make it easy for you
Every regulatory & commercial pathway under one roof
- End-to-end coverage — regulatory, quality, manufacturing, market access
- Single accountable team — one point of contact across every milestone
- Specialized service lines — click any sphere to explore that service
Trusted by medical device innovators
ISO 13485CDSCO RecognizedCE / MDRBISNABL Network
CDSCO MD Certifications
Every CDSCO form, one click away.
42 forms across 12 thematic categories — scroll to reveal more.
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CDSCO MD Certifications
Every CDSCO form, one click away.
42 forms across 12 thematic categories.
Why us
Why Leading Medical Device Companies Choose Us
Twelve years of CDSCO-recognized practice, a founder-led team, and a 95% first-pass approval rate — that's the bar we hold ourselves to on every engagement.
Two decades of regulatory depth
Founder-led team with 20+ years inside CDSCO, ISO 13485, CE/MDR, and FDA filings — every dossier is reviewed by a senior expert.
400+ approvals across India & EU
From agile startups to Fortune 500 manufacturers — Class A through Class D devices, IVDs, and combination products.
95% first-pass approval rate
Our dossiers are built to anticipate every reviewer query — most submissions clear without a single resubmission round.
Transparent, milestone-based pricing
Fixed scopes, clear deliverables, no scope creep. You see every milestone and timeline before we start.
CDSCO-recognized authorized agent
We can serve as your Authorized Indian Agent — handling renewals, vigilance, and ongoing compliance for foreign manufacturers.
One partner, end-to-end
Regulatory + quality + clinical + market access under one roof. No hand-offs between vendors, no information loss.
Industries
Sectors we specialize in
Deep regulatory expertise across the medical device ecosystem — from low-risk disposables to high-risk active implantables and combination products.
In-Vitro Diagnostics
Reagents, instruments, and IVD assays — full PER lifecycle.
Wearable Health Tech
Continuous monitors, smart patches, biosensors.
Surgical Equipment
Reusable + single-use surgical instruments and energy devices.
Drug-Device Combos
Pre-filled syringes, drug-eluting stents, inhalers.
What we deliver
Full-stack regulatory under one roof
From device classification to post-market surveillance — we own every milestone so your team can focus on the product.
CDSCO Licensing
End-to-end submission management — MD-3, MD-5, MD-9, MD-15 — across Class A/B/C/D devices.
ISO 13485 QMS
Gap analysis, documentation, internal audits, and certification body liaison — fully turnkey.
Clinical Investigation
Protocol design, IRB engagement, monitoring, and PER preparation that holds up to scrutiny.
Legal Metrology (LMPC)
Label compliance, packaging declarations, and importer/manufacturer registration — done right the first time.
EPR Registration
Extended producer responsibility filings, e-waste compliance, and ongoing return-report management.
Authorized Indian Agent
CDSCO-recognized license-holder representation for foreign manufacturers entering India.
How we work
From idea to approval — without surprises
A transparent four-step engagement with clear milestones, fixed scopes, and your team in the loop the whole way.
01
Discovery & gap analysis
We assess your device, target markets, and current readiness — then propose the optimal regulatory pathway.
02
Documentation & dossier
Technical files, predicate analysis, risk management, clinical evidence — assembled to CDSCO/MDR standards.
03
Submission & follow-up
We file, respond to queries, and liaise with regulators until your approval lands.
04
Launch & lifecycle
Post-approval surveillance, variations, renewals, vigilance reports — fully managed.
What to expect
A typical approval journey
Six milestones. Real-world timing on a Class B/C medical device — yours may move faster.
Day 1
Discovery
Free 30-min scoping call. We assess device, target markets, and risk class.
Week 1
Strategy Roadmap
Written pathway document. Predicate analysis, regulatory standards, timelines.
Week 2-4
Dossier Build
Technical file assembly, risk management, clinical evaluation, labelling.
Week 5
Submission
Filed via SUGAM / e-portal. Acknowledgement + tracking dashboard.
Week 6-8
Query Response
Reviewer queries handled within 48 hours. Most cleared in one round.
Week 8-12
Approval
License in hand. Hand-off package + post-market plan included.
300+
Devices approved
across Class A–D submissions
45d
Avg. approval time
after dossier submission
95%
First-pass approval
no resubmission needed
14+
Years of expertise
CDSCO, CE, ISO 13485
Nitin Gupta
Founder & Director
Meet our founder
Founder & Director
“Our goal isn't just to achieve compliance; it's to build a foundation of quality that empowers healthcare innovation to thrive globally.”
Nitin Gupta founded Bio-State Consulting in 2012 with a clear vision: to demystify the complex regulatory landscape for medical device manufacturers. With over two decades of specialized experience in healthcare regulations, quality management systems, and strategic market access, he has positioned Bio-State as a critical bridge between innovation and compliance.
Under his leadership, the firm has successfully guided over 400 companies— from agile startups to Fortune 500 giants — through the intricacies of CDSCO, FDA, and CE mark approvals. Nitin's philosophy centers on proactive compliance, viewing regulatory requirements not as hurdles, but as essential frameworks that guarantee patient safety and product efficacy.
His deep technical expertise, combined with a relentless commitment to client success, continues to drive Bio-State's expansion as a globally recognized leader in regulatory affairs consulting.
Leadership
Meet Our Expert Team
Decades of combined experience across regulatory affairs, clinical, quality, and international compliance — every project is led by a senior specialist.
YC
Yogesh Chaturvedi
GM Operations
34 years of comprehensive expertise in regulatory affairs, operations management, and strategic compliance planning for global markets.
SS
Sanjay Singh
Regulatory Head
24+ years of specialized experience in medical device regulatory compliance, CDSCO submissions, and quality management systems.
GG
Dr. Gupteshwar Gupta
Senior Regulatory Expert
Leading specialist in clinical studies, Performance Evaluation Reports (PER), and rigorous clinical data analysis for high-risk devices.
SS
Saloni Srivastava
Regulatory Coordinator
Expert in managing complex CDSCO submissions, technical dossier preparation, and maintaining seamless regulatory documentation.
SS
Santosh Singh
Manager Regulatory Affairs
Specialist in international regulatory frameworks, import/export licensing, and cross-border compliance strategies.
AV
Arpit Vishnoi
Manager Regulatory Affairs
Dedicated expert in ISO 13485 certifications, quality management system implementation, and facility compliance audits.
DK
Danish Khursheed
Application Manager
Specialist in navigating the GeM portal, managing government procurement processes, and facilitating OEM panel approvals.
Case studies
Approvals that moved markets
Real engagements, real outcomes. A glimpse at how we've helped manufacturers, importers and innovators reach the market faster.
Regulatory · LicensingRead the case study
Import, Test & Manufacturing License for an IVD company
Licenses secured for import, testing, and manufacturing
An IVD company planning to import diagnostics into India while establishing local manufacturing secured its licenses through complete, compliant submissions.
Approved
Test License
Granted
Manufacturing License
ISO 13485 · QMS
ISO 13485 certification for an In Vitro device startup
ISO 13485 certification achieved
Achieved
ISO 13485 cert
Complete
QMS documentation
Market Access · Launch
India market launch for an international manufacturer
Successful market launch in India
Launched
Indian market
Defined
Market-entry strategy
Client outcomes
What Our Customers Say
Real stories from real people — and the concrete numbers behind them.
FAQ
Frequently asked questions
Quick answers to the most common questions about regulatory pathways, timelines, and how we work. Need something specific?
Ask us directlyFor a Class B/C medical device with a clean technical file, expect 8–12 weeks from submission to license. Class A is faster (4–6 weeks), Class D and clinical-investigation routes can take 6–9 months. Our 95% first-pass rate means most clients avoid resubmission rounds entirely.
Yes — we serve as your CDSCO-recognized Authorized Indian Agent. You retain full IP and commercial control while we handle licensing, vigilance, renewals, and variations under our local registration.
Absolutely. We design technical files that satisfy multiple jurisdictions at once. A single CER, risk file, and clinical evaluation can support CDSCO + EU MDR + (with adjustments) US FDA filings — saving you 4–6 months of duplicate work.
Gap analysis (1 week), SOP and documentation rollout (4–6 weeks), staff training, internal audit, and certification-body liaison. Most clients are audit-ready in 8–10 weeks for the Stage 1 audit.
Fixed-scope milestone pricing — no hourly billing, no scope creep. You see every deliverable, timeline, and cost before we start. Retainer arrangements are available for ongoing lifecycle work.
Included in our fixed scope. Most queries are answered within 48 hours by our senior consultants. Our dossiers are built to anticipate reviewer concerns, so most submissions clear without any queries at all.
Yes — roughly 40% of our clients are pre-revenue or in seed stage. We help shape regulatory strategy before you finalize design, which often saves significant rework. Founder-friendly engagement structures available.
We handle ongoing MDR (medical device reporting), PMS reports, PSUR / PER updates, adverse-event triage, and field-safety corrective actions. Annual retainer covers everything an authorized license holder needs.
Currently accepting Q3 engagements
Ready to file with confidence?
Tell us about your device and target markets. A senior consultant responds within 24 hours with an indicative timeline and fixed-fee quote — at no cost.
400+
Approvals delivered
95%
First-pass rate
14d
Avg. dossier turn
24h
Response SLA
No-cost scoping callFixed-fee quotesSenior consultant on every project