Grow your business with us!
Grow your business with us!
Empowering Medical Device Manufacturers to Achieve Compliance and Market Access
MedReg Consultancy helps medical device and IVD manufacturers achieve smooth approvals and compliance in global markets. Since 2011, we’ve supported companies across India, Europe, the USA, and the UK with expert guidance and practical strategies, covering products from surgical disposables and orthopaedic implants to sutures, diagnostic consumables, and laparoscopic devices.
- Listening to customer needs
- Understanding the scope clearly
- Defining the right regulatory pathway
- Maintaining transparency in documentation
- Delivering cost-effective strategies
- Ensuring timely reporting and advice
- Following a preventive approach
10+
Year Of Experience
our comprehensive service offerings
Backed by a team of experts, we offer seamless regulatory and technical services to streamline your project.
India
- Manufacturing License
- Import License
- Clinical Trails
- Free Sale Certificate
- Product Endorsement
- Retention of License
- Market Standing Certificate
- Non-conviction Certificate
- Labeling Review
- Product Development
- Authorized Agent
- Wholesale License
- Sterilization Process Validation
- QMS Documentation
- Device master File Preparation
- Voluntary Registration
- Neutral Code
- Internal Audit
- AMC – Annual Maintenance contract services for documentation
Europe
- Technical master File Preparation
- Gap Analysis
- Clinical Evaluation
- Post Market Surveillance Report
- Risk Analysis as per EN ISO 14971
- General Safety And Performance Requirement
- Medical Device Classification
- Sterilization Validation
- CE mark (Medical Device and IVD)
- Person Responsible for Regulatory Compliance
- Cleaning & Disinfection Validation
- AMC – Annual Maintenance contract services for documentation
- Authorized Agent Service through active Channel partner
- Establishment and Listing
- GUDID Submission
- QMS Implementation- QMSR
- Premarket Submission-510K
- Q-Submission
- US Agent Service
- 483 Response and submission
- Complaint File Submission
- E-Copy Guidance
- Small Business Documentation
- Interactive Discussion with FDA after Submission
- Responding to Additional Information
- GMP compliance for USFDA inspection.
Other
- QMS Documentation
- Internal Audit
- Process Validation
- Supplier Development, Inspection, Evaluation
- Technical File/ Dossier Preparation as per IMDRF and GHTF guideline
Number speaks everything
Our numbers tell a story of growth, trust, and proven success. Every result reflects our expertise, commitment, and measurable impact.
2k+
Complete Project
20+
Countries Served
950+
Clients Served
250+
service offerings
Why Choose Medreg
Expert consultants, thorough regulatory insight, and a seamless path to compliance, that’s our promise for your medical devices.
Focused on Your Goals
Your challenges guide our approach. By actively listening, we design focused strategies that deliver measurable, result-driven outcomes.
Simplifying Complexity
We decode Complex regulatory requirements and define a clear, actionable pathway, to ensure your projects move forward efficiently and compliantly.
Comprehensive Understanding
We dive deep into your requirements, identifying all critical factors to ensure our solutions address every aspect of your regulatory needs.
Documentation You Can Trust
As experts, we provide clear, accurate, and accessible documentation, keeping you informed at every stage of your project.
Real Feedback from Real Clients
MedReg Consultancy demonstrated exceptional expertise throughout our collaboration. The team is professional, dedicated, and consistently focused on delivering results. Their guidance and execution exceeded our expectations. We strongly endorse their services.
MedReg Consultancy has been exceptional in helping us address a wide range of regulatory queries. Their expertise and in-depth regulatory knowledge place them alongside the world’s leading regulatory consultants.
Our experience working with MedReg Consultancy has been excellent. The team is highly experienced, knowledgeable, results-oriented, and professional in both training and project execution. We strongly recommend their services for all medical device regulatory needs.
Accelerate your journey!
Our Clients
Almost 950+ Clients
Certification Success, Without the Stress
Compliance Made Simple–Start with a Free Consultation
Get the Answers You Need to Move Forward.
Navigating medical device regulations doesn’t have to be overwhelming. At MedReg Consultancy, we’ve answered the most common client questions to quickly guide you through our services and how we can support your compliance journey. From emerging startups to established global players, our FAQs are your first stop. Need personalised help? We’re just a message away!
We provide end-to-end regulatory solutions for the medical device industry, including assistance with certifications, licenses, compliance strategies, documentation, and regulatory submissions across domestic and international markets.
Our team supports a wide range of certifications and licenses, including ISO 13485, CE marking, FDA approvals, local regulatory registrations, and other compliance requirements for medical devices in various countries.
Absolutely. We work with startups and established manufacturers alike, providing guidance on regulatory pathways, documentation, and strategies to ensure smooth approvals and market entry.
Our team consists of 100+ specialists with extensive knowledge and experience in global and local medical device regulatory requirements, ensuring expert guidance for every project.