CE markingEU MDR 2017/745 · IVDR 2017/746
Europe Regulatory Services
From device classification and technical documentation to conformity assessment and Notified Body coordination, we provide structured guidance throughout your CE marking journey.
RegulatorEuropean Commission · EU Notified Bodies
- EU MDR 2017/745
- EU IVDR 2017/746
- CE marking
24 servicesExplore Services
US FDA21 CFR Part 807 · Part 820
USA Regulatory Services
FDA classification, establishment registration and listing, 510(k), Q-Submissions, GUDID, labelling, QMSR and post-market reporting.
RegulatorU.S. Food and Drug Administration (FDA)
- US FDA 510(k)
- 21 CFR Part 820 (QMSR)
- UDI / GUDID
18 servicesExplore Services
Quality systemsISO 13485:2016 · MDSAP
QMS & Global Regulatory Services
ISO 13485 QMS documentation, risk management, design and development files, MDSAP readiness, country-specific QMS requirements, turnkey projects and training.
RegulatorISO · MDSAP (USA, Canada, Brazil, Japan, Australia)
- ISO 13485:2016
- MDSAP
- ISO 14971
14 servicesExplore Services
CDSCOMedical Devices Rules, 2017
India Regulatory Services
Manufacturing and import licences, registrations, certificates and QMS documentation under the Medical Devices Rules, 2017 (CDSCO).
RegulatorCDSCO – Central Drugs Standard Control Organisation
- CDSCO
- Medical Devices Rules, 2017
19 servicesExplore Services
Markets at a glance
| Market | Authority / framework | What we support |
|---|---|---|
| Europe | EU MDR 2017/745 and EU IVDR 2017/746 | CE marking: EUDAMED, UDI, gap analysis, risk management, EU AR, PRRC, GSPR, technical documentation, PMS, clinical evaluation, PMCF, conformity assessment and more |
| USA | US FDA (21 CFR) | 510(k), establishment registration and listing, Q-Submissions, GUDID, labelling, QMSR (21 CFR 820), MDR reporting, U.S. Agent |
| QMS & global | ISO 13485:2016, MDSAP, ISO 14971, country-specific QMS (Australia, Brazil, Canada, Japan, USA) | QMS documentation, risk management file, design and development files, clinical evaluation, PMS, MDSAP gap analysis, Notified Body identification, turnkey projects and training |
| India | CDSCO, Medical Devices Rules, 2017 | Manufacturing and import licences (MD-5, MD-6, MD-9, MD-10, MD-15), registrations, certificates, Authorized Agent, QMS documentation |
Our approach
Listening to customer needs
We start with your device, your target markets and your timelines.
Understanding the scope clearly
We identify every requirement that applies to your product and organisation.
Defining the right regulatory pathway
We set out the route to market, the documents needed and a realistic plan.
Maintaining transparency in documentation
We prepare and review documentation with you, keeping you informed at every stage.
Ensuring timely reporting and advice
We support submissions and queries, and keep you compliant after approval with a preventive approach.
Training & professional development
Corporate training on ISO 13485, ISO 14971, EU MDR, US FDA 510(k), biological evaluation, sterilization validation and more.
MedReg provides regulatory consultancy. Certificates, clearances, approvals and licences are issued by the relevant regulatory authorities, Notified Bodies and certification bodies. Marks and framework names are shown only to identify the requirements we support.
Consultation
Not sure which pathway applies to your device?
Tell us about your device and target markets. +91 88664 61989 (IST, UTC+05:30) · enquiry@medreg.in
Confidential & Audit-Proof
Request a consultation
Direct confidential advisory with senior CDSCO, CE MDR, and FDA specialists.
