REGULATORY EXPERTISE
CE · FDA · CDSCO · Global Markets
STRATEGY & SOLUTION
Product & Market specific.
END TO END SUPPORT
Documentation to approval
About us
Precision Solutions, Strategic Brilliance
At Medvice, we combine strategic regulatory insight with technical precision to guide medical device companies through every stage of the compliance journey.
From building a robust QMS, to achieving CE/FDA approvals,and managing global registrations, we help our clients achieve faster, smoother market approvals without compromising quality or safety.
Let's work together to find precise solutions and innovate regulatory strategies to make your success journey simple.
Services
India
Device Registration
Indian Authorized Agent Support
Device Classification & Regulatory Strategy
Import & Test Licence
Manufacturing & Loan Licence
CDSCO Query & Audit Support
European Union
EU MDR 2017/745
EU IVDR 2017/746
CE Marking Strategy
Technical Documentation
EUDAMED & UDI
Notified Body Submission & Query Support
United States
US FDA Regulatory Strategy
Device Classification
Predicate Assessment
510(k) Submission Support
Registration & Listing
UK & Other Market
UKCA / MHRA
MDSAP
Country-specific Regulatory Strategy
International Device Registrations
Market Lifecycle
PMS • PSUR • Change Impact Assessment
PMCF / PMPF • Regulatory Intelligence
Complaint Handling
Vigilance & Regulatory Reporting
FSCA / Recall Support • CAPA
Periodic Technical Documentation Updates
Management
US FDA Regulatory Strategy
Device Classification
Predicate Assessment
510(k) Submission Support
Registration & Listing
Clinical Evaluation
CEP • CER • Literature Search & Review
Post-Market Clinical Follow-up
PMCF Plan • PMCF Evaluation Report
IVD Performance Evaluation
BEP • BER • ISO 10993 Strategy
Performance Evaluation Plan & Report
Scientific Validity • Analytical Performance • Biological Evaluation
Testing & Validation
EO • Gamma • Steam
Sterilization Validation
Cleanroom & Environmental Control
ISO 14644 • EN 17141
Packaging & Transportation Validation
ISO 11607 • ASTM • ISTA
Biocompatibility • ISO 10993
Electrical Safety & EMC
Software Verification & Validation
Technical Document
EU MDR/IVDR Technical Documentation
Device Master File
Design & Development Documentation
Essential Principles / GSPR
Risk Management • ISO 14971
Usability Engineering • IEC 62366
Labelling & IFU
Insights
Regulatory Insights :
Practical perspectives on evolving medical device regulations, standards and compliance requirements.
Contact us
Testimonial 1
“Medvice Consultants has provided thorough, clear, and reliable guidance throughout our regulatory journey in India. Their dedication, professionalism, and strong sense of ownership have been commendable. We highly recommend their services for navigating complex regulatory requirements.”
Regulatory Service: CDSCO MD-15 Import Licence
Medical Device: CO₂ Incubators
Testimonial 2
“Working with Medvice Consultants has been an excellent experience. Their team seamlessly
integrates with ours, bringing exceptional regulatory expertise, practical guidance, and a strong commitment to our objectives. Their professionalism and dedication make them a valuable regulatory partner.”
Regulatory Service: CDSCO MD-9 Manufacturing Licence & ISO 13485
Medical Device: IVD Assay, Analyzer & Software as a Medical Device (SaMD)
Testimonial 3
“Medvice Consultants has been a reliable partner in navigating complex regulatory requirements.
Their expertise, practical approach, and prompt support have been invaluable. The team is
professional, responsive, and committed to delivering effective solutions. We gladly recommend their regulatory consulting services.”
Regulatory Service: EU MDR– Annual Regulatory and QMS Compliance Support (AMC)
Medical Devices: Disposable Medical Devices
