Medonix provides regulatory affairs, quality assurance, and clinical documentation consulting for medical device manufacturers — across CDSCO, EU MDR, and USFDA.
Medonix clients shift from reactive to proactive compliance — working smarter, faster, and with full regulatory confidence.
Startups to established OEMs across India, Europe, and the USA.
We design and implement Quality Management Systems calibrated to your device class — structured for audit readiness from day one.
End-to-end Indian device registration under MDR 2017 — from classification to import licence applications and renewals.
Full EU MDR 2017/745 support — technical documentation, clinical evaluation, PMCF, and notified body liaison.
Strategic US market entry — predicate analysis, pre-submission meetings, and full 510(k) submission management.
Structured audit programmes that surface non-conformities before external auditors do, paired with practical CAPA plans.
GCP-aligned study protocols, case report forms, and informed consent forms — ready for ethics committees and regulatory submission.
Every engagement follows four clear phases so you always know where your device stands.
Classification, intended use, regulatory gaps, and target market analysis before anything is written.
Pathway selection, submission type, documentation roadmap, and a realistic timeline agreed upfront.
Technical file preparation, QMS build, clinical documents, and submission — all to regulatory standard.
Query handling, audit support, post-market vigilance, and lifecycle compliance.
CDSCO registration & import licences under MDR 2017.
QMS implementation and certification readiness.
EU MDR technical documentation, CER, and notified body liaison.
USFDA 510(k) strategy, predicate analysis, and submission.
Study protocols, CRF and ICF drafting aligned to GCP and regulatory requirements for your target markets.
We bring specialist depth and genuine partnership to every engagement.
Deep, multi-jurisdiction experience across CDSCO, EU MDR, and USFDA under one roof.
No generalist consulting — every project led by someone who lives device regulation.
Every plan built around your device, your markets, and your existing documentation.
We start with your current state, not a template — so the pathway fits your product.
Structured methodology that shortens timelines without cutting corners on compliance.
Planning the pathway before drafting avoids the costly rework that slows most submissions.
We embed in your process and build your team's capability alongside our contribution.
Our goal is a team that understands its regulatory position long after our engagement ends.
"Medonix's structured approach and clear communication made our CDSCO registration process smooth and predictable. They knew exactly what was needed."
"Their EU MDR technical documentation was exceptional — the CER held up under notified body review without a single deficiency."
"Working with Medonix on our 510(k) gave us clarity we hadn't had before. Predicate selection, Q-Sub, FDA correspondence — all handled seamlessly."
"The ISO 13485 QMS they built wasn't just audit-ready — it genuinely improved how our team works day to day. A practical, lasting outcome."
"Their clinical affairs team drafted our study protocol and ICF in record time. Both cleared ethics committee review without revisions."
"Trusted advisors and true partners in managing our Quality Management and Regulatory Affairs journey. Highly recommend."
"Medonix's structured approach and clear communication made our CDSCO registration process smooth and predictable. They knew exactly what was needed."
"Their EU MDR technical documentation was exceptional — the CER held up under notified body review without a single deficiency."
"Working with Medonix on our 510(k) gave us clarity we hadn't had before. Predicate selection, Q-Sub, FDA correspondence — all handled seamlessly."
"The ISO 13485 QMS they built wasn't just audit-ready — it genuinely improved how our team works day to day. A practical, lasting outcome."
"Their clinical affairs team drafted our study protocol and ICF in record time. Both cleared ethics committee review without revisions."
"Trusted advisors and true partners in managing our Quality Management and Regulatory Affairs journey. Highly recommend."
A practical guide to determining your device class and the correct regulatory pathway under CDSCO.
Read ArticleThe key elements notified bodies look for in a Clinical Evaluation Report, and how to prepare yours.
Read ArticleHow predicate device selection affects your 510(k) strategy and what FDA looks for in your comparison.
Read ArticleSeven specialist services covering the complete medical device regulatory lifecycle — from quality systems to clinical documentation.
Global regulatory frameworks are rigorous and constantly evolving. Medonix provides the depth to navigate them — without building that capability in-house.
We design and implement a Quality Management System calibrated to your device class, headcount, and manufacturing complexity — structured for audit readiness from the start. Our approach integrates risk-based thinking so your QMS is genuinely useful in daily operations, not just compliant on paper.
End-to-end support for Indian device registration under MDR 2017 — from device classification and technical file preparation to import licence applications. We understand the practical nuances of CDSCO review cycles, helping you avoid delays that catch first-time applicants off guard.
Full EU MDR 2017/745 pathway support — covering technical documentation, clinical evaluation, post-market clinical follow-up, and notified body liaison. We build a Technical File designed to hold up under the most rigorous notified body scrutiny.
Strategic and documentary support for US market entry — from predicate device analysis and pre-submission meetings through to 510(k) submission management. We prepare eSTAR-ready submissions that minimise rounds of deficiency correspondence with FDA.
Structured internal audit programmes that identify non-conformities before external auditors do — paired with actionable CAPA plans. We provide honest findings rather than checkbox audits, so issues get resolved before certification or surveillance audits.
Regulatory training programmes and complete SOP libraries that build lasting in-house competence — tailored to your team's roles and quality system requirements. We design training people actually retain, not generic slides nobody remembers a month later.
GCP-aligned clinical documentation support — from study design through to final document packages ready for regulatory submission. We prepare protocols and consent materials that satisfy ethics committees and regulators alike, without unnecessary back-and-forth revisions.
A quick reference for the regulatory scope of every Medonix service.
| Service | India (CDSCO) | Europe (EU MDR) | USA (USFDA) | Global QMS |
|---|---|---|---|---|
| ISO 13485:2016 QMS | ✓ | ✓ | ✓ | ✓ |
| CDSCO Submissions | ✓ | — | — | — |
| EU MDR Compliance | — | ✓ | — | — |
| USFDA 510(k) / PMA | — | — | ✓ | — |
| Internal Audit & Gap Analysis | ✓ | ✓ | ✓ | ✓ |
| Training & SOP Development | ✓ | ✓ | ✓ | ✓ |
| Clinical Affairs | ✓ | ✓ | ✓ | — |
Medonix exists to make global regulatory compliance achievable — without the overhead of building expertise in-house.
Every regulatory delay is a delay for the patients who need your device. Medonix was founded to close that gap — not just by filing paperwork, but by embedding the right expertise at the right time in your product journey.
We believe regulatory affairs is a strategic function, not a compliance checkbox. When it's done well, it builds trust with regulators, strengthens product quality, and creates a competitive advantage in global markets.
Our team understands not just what the regulations say, but how regulators interpret and apply them in practice — across CDSCO, EU MDR, and USFDA.
Built exclusively for medical device manufacturers — no generalist consulting, no scope creep.
Expanded to cover CDSCO, EU MDR, and USFDA simultaneously — one partner for every major market.
GCP-aligned protocol, CRF, and ICF preparation added as clinical evidence became central to modern pathways.
From first regulatory strategy session to post-market surveillance, every stage covered.
These aren't values written for a website. They're how we actually work.
Every submission, technical file, and SOP crafted with the care of a document facing regulator review.
We plan before we document. The right strategy saves months of rework.
We integrate with your team, building your internal capability alongside our contribution.
No jargon, no vague timelines. You'll always know where your process stands.
Our team spans every dimension of medical device compliance — quality systems architecture to clinical investigation design.
Share your regulatory challenge — where you are, where you need to be, and which markets matter. We respond within one business day.
A specialist reviews your message and identifies which expertise areas are most relevant to your device and markets.
Targeted questions or an invitation to a discovery call — no generic auto-responses.
We map your regulatory position against your target markets and surface what needs to happen first.
Clear scope, timeline, and commercial proposal. Once agreed, we get to work immediately.
The more context you share, the more useful our first response will be.
Thank you for reaching out to Medonix. A specialist will review your enquiry and respond within one business day.
Quick answers before starting an engagement with Medonix.