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Supporting Medical Device Companies to Achieve CE Certification and Market Presence Across Europe
Building Stronger MedTech Futures Through Compliance in Europe
MedReg Consultancy helps medical device manufacturers confidently navigate Europe’s regulatory landscape. From CE certification, ISO 13485:2016, MDSAP, ICMED, and UK MDR to technical documentation, clinical evaluations, and post-market surveillance, we deliver complete end-to-end solutions. As your trusted partner, we simplify every stage, from device classification and gap analysis to representation, documentation, and registrations, ensuring long-term compliance and competitiveness in the European MedTech market.
Services We Offer in Europe
As a top regulatory solutions provider for medical devices, we deliver these services across the European market.
CE mark
Obtaining CE Mark certification is essential for medical device companies seeking compliance and market access in Europe. At MedReg Consultancy, we streamline the entire process, from regulatory assessment and technical file preparation to audits and approvals, helping you achieve CE certification efficiently and confidently.
Technical master File Preparation
Preparing a comprehensive Technical Master File is crucial for medical device companies to demonstrate compliance with European regulations. At MedReg Consultancy, we manage the entire process, from compiling technical documentation and risk assessments to ensuring alignment with CE requirements, helping you maintain accuracy and regulatory readiness with confidence.
Gap Analysis
Conducting a gap analysis is vital for medical device companies to identify regulatory compliance gaps and streamline market entry in Europe. At MedReg Consultancy, we evaluate your existing processes and documentation against EU requirements, providing clear recommendations to bridge gaps and ensure your products meet all regulatory standards efficiently and confidently.
Clinical Evaluation
Performing a clinical evaluation is essential for medical device companies to demonstrate safety and performance compliance in Europe. At MedReg Consultancy, we manage the entire process, from reviewing clinical data and literature to preparing evaluation reports in line with EU regulations, helping you achieve regulatory approval efficiently and confidently.
General Safety And Performance Requirement
Meeting the General Safety and Performance Requirements is crucial for medical device companies to ensure compliance with European regulations. At MedReg Consultancy, we assess your products against GSPR standards, prepare necessary documentation, and provide guidance to help you achieve regulatory approval efficiently and confidently.
Post Market Surveillance Report
Preparing a Post-Market Surveillance (PMS) report is essential for medical device companies to monitor product safety and compliance in Europe. At MedReg Consultancy, we guide you through data collection, analysis, and report preparation, helping you maintain regulatory adherence and ensure continuous product safety with confidence.
Risk Analysis as per EN ISO 14971
Conducting a risk analysis as per EN ISO 14971 is critical for medical device companies to ensure product safety and regulatory compliance in Europe. At MedReg Consultancy, we assess potential risks, implement mitigation strategies, and prepare detailed reports, helping you meet EU requirements efficiently and confidently.
Person Responsible for Regulatory Compliance
Designating a Person Responsible for Regulatory Compliance (PRRC) is mandatory for medical device companies under EU regulations. At MedReg Consultancy, we assist in identifying, training, and supporting the PRRC, ensuring all regulatory obligations are met efficiently and with full confidence.
Medical Device Classification
Accurate medical device classification is essential for compliance with European regulations and determining the appropriate regulatory pathway. At MedReg Consultancy, we assess your products, classify them according to EU rules, and guide you through the necessary compliance requirements, ensuring a smooth and confident market entry.
Sterilization Validation
Sterilisation validation is critical for medical device companies to ensure product safety and compliance with European regulations. At MedReg Consultancy, we plan, execute, and document sterilisation validation processes, helping you meet EU standards efficiently and with complete confidence.
Cleaning & Disinfection Validation
Cleaning and disinfection validation is essential for medical device companies to ensure safety, effectiveness, and compliance with European regulations. At MedReg Consultancy, we design, execute, and document validation processes, helping you achieve regulatory adherence efficiently and with full confidence.
AMC – Annual Maintenance contract services for documentation
Maintaining up-to-date regulatory documentation is crucial for ongoing compliance in the European market. At MedReg Consultancy, we offer Annual Maintenance Contract (AMC) services to manage, update, and audit your documentation regularly, ensuring your medical devices remain fully compliant with EU regulations.
Authorized Agent Service through active Channel partner
Having a reliable Authorised Agent is essential for medical device companies to meet European regulatory requirements. At MedReg Consultancy, we provide Authorised Agent services through our active channel partners, ensuring smooth regulatory communication, compliance, and market access across Europe.
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
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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 provide end-to-end regulatory solutions, including CE marking, technical master file preparation, gap analysis, clinical evaluation, risk analysis (EN ISO 14971), sterilisation and cleaning validation, post-market surveillance reports, and Authorised Agent services, helping your medical devices meet stringent EU requirements efficiently.
Our team streamlines the entire CE certification process, from regulatory assessment and technical file preparation to audits and approvals, ensuring your devices comply with European standards and gain market access confidently.
Yes! We offer Annual Maintenance Contract (AMC) services for documentation updates, regulatory audits, and continuous monitoring, helping your devices maintain compliance and safety across the European market.
Designating a PRRC is mandatory under EU regulations. At MedReg Consultancy, we help identify, train, and support the PRRC, ensuring all regulatory obligations are consistently met.
Absolutely! Through our Authorised Agent services and active channel partners, we provide regulatory representation, country registration support, and free sale certificates, enabling smooth market access and compliance for your medical devices.