EU MDR Consultant for Chinese Manufacturers
Supporting CE Marking and EU Market Access under MDR 2017/745. Expert regulatory guidance for medical device manufacturers seeking to enter the European market.
Request ConsultationComprehensive EU MDR Support
From initial assessment to CE marking, we provide end-to-end regulatory support for medical device manufacturers entering the European market.
EU MDR 2017/745 Compliance
Full regulatory support for medical device compliance under the European Medical Device Regulation, including classification, conformity assessment and market surveillance requirements.
CE Marking Strategy
Strategic guidance for obtaining CE marking, including selection of conformity assessment routes, notified body liaison and declaration of conformity preparation.
Technical Documentation
Comprehensive preparation of Technical Documentation according to MDR Annex II and Annex III requirements, ensuring all essential requirements are properly addressed.
ISO 13485 Implementation
Support for implementing and maintaining a Quality Management System compliant with ISO 13485:2016, the international standard for medical device manufacturers.
ISO 14971 Risk Management
Expert guidance on risk management processes according to ISO 14971, including risk analysis, evaluation, control and post-production monitoring.
Support for Non-EU Manufacturers
Specialized assistance for manufacturers outside the European Union, including EU Authorized Representative requirements and import documentation.
Your Trusted EU Regulatory Partner
We offer a personalized, cost-effective approach to regulatory consulting with direct expert access and flexible support.
Freelance Expert
Cost-efficient personalized service compared to large consulting firms. Direct communication with your dedicated regulatory specialist.
Fast & Flexible Support
Agile response times and adaptable workflows to meet your project timelines and specific requirements.
International Experience
Proven track record working with manufacturers from China and other international markets entering the European Union.
Your Path to CE Marking
A structured approach to guide your medical device from assessment to successful European market entry.
Initial Assessment
We analyze your product, current documentation and regulatory status to identify gaps and requirements for EU market access.
Regulatory Strategy
We develop a customized roadmap including classification, conformity assessment route and timeline for CE marking.
Documentation Preparation
We prepare or review your Technical Documentation, risk management file and quality management system documentation.
CE Marking & Compliance
We guide you through the conformity assessment process and support you until successful CE marking and market placement.
Request a Consultation
Tell us about your medical device and regulatory needs. We will respond within 24 business hours with an initial assessment and proposal.
Cosmetic Regulatory Support for EU Market
In addition to medical devices, we provide comprehensive regulatory support for cosmetic products entering the European market under Regulation (EC) 1223/2009.
Ready to Enter the European Market?
Contact us today for a free initial consultation. We will help you navigate EU regulations and achieve CE marking for your medical devices.
Request Consultation