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Supporting Medical Innovators Worldwide With Multi-Market Regulatory Strategy And Execution
Empowering Medical Technology Manufacturers Worldwide
MedReg Consultancy empowers medical device manufacturers to expand globally with confidence. From ISO 13485:2016, CE, UK MDR, USFDA, CDSCO, and UL certifications to registrations, submissions, and post-market support, we deliver comprehensive regulatory solutions tailored to international markets. Backed by global partnerships, our expertise ensures compliance, growth, and competitiveness across the MedTech landscape.
Services We Provide
We offer services that help you launch your medical technology in the Middle East, Southeast Asian Countries, Brazil, TGA, and Canada.
Technical File/ Dossier Preparation as per IMDRF and GHTF guideline
MedReg Consultancy streamlines Technical File and Dossier preparation, ensuring IMDRF/GHTF compliance and country-specific alignment for faster approvals and smooth market entry across global markets.
QMS Documentation
MedReg Consultancy simplifies QMS documentation with ISO 13485:2016 and QMSR-aligned SOPs, manuals, and records, ensuring audit-ready, compliant, and approval-focused systems.
Internal Audit
Internal audits are vital for maintaining regulatory compliance. At MedReg Consultancy, we evaluate your quality management system, identify gaps, and provide guidance on corrective actions to strengthen compliance and ensure inspection readiness with confidence.
Supplier Development, Inspection, Evaluation
Reliable suppliers are key to quality and compliance. At MedReg Consultancy, we handle supplier development, audits, and performance monitoring to ensure a strong, compliant supply chain and smooth market access.
Process Validation
Process validation ensures consistent product quality and regulatory compliance. At MedReg Consultancy, we plan, execute, and document validation activities to help you minimize risks and achieve smooth approvals with confidence.
Certification Success, Without the Stress
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.
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
Accelerate your journey!
Our Clients
Almost 950+ Clients
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 help medical device manufacturers expand into markets including the Middle East, Southeast Asia, Brazil, Australia (TGA), and Canada, providing tailored regulatory strategies and end-to-end support for compliance and market access.
Our services include Technical File/Dossier preparation in accordance with IMDRF and GHTF guidelines, QMS documentation, internal audits, supplier development and evaluation, process validation, country registrations, CE/ISO/USFDA certifications, and post-market surveillance. We guide your products through all stages of regulatory approval.
We ensure full compliance with IMDRF and GHTF guidelines, managing documentation, data compilation, formatting, and submission. Our expertise helps you prepare robust, regulator-ready dossiers aligned with country-specific requirements for faster approvals and smooth market entry.
Yes. We provide internal audit services, supplier audits, process validation, QMS maintenance, and corrective action guidance, ensuring your quality management system remains compliant, inspection-ready, and continuously improving across global markets.
MedReg offers expert consultants, deep regulatory insight, and a seamless approach to compliance. We simplify complex requirements, provide accurate documentation, and implement proactive strategies to reduce risks, ensuring your medical devices remain compliant and competitive worldwide.