services

Providing consulting services in the fields of MDR, CE, EU legal representation, market development, specialized training and compliance with European legislation - with international experience.

In today’s landscape of stricter regulations, tougher competition, and higher risks, working with a qualified consultant in medical devices and pharmaceutical products can make the difference between failure and success.
With years of expertise in regulatory affairs, CE marking, EU representation, international certification, and market expansion, we help you enter the European market faster, legally, and with minimal risk.

Our services

1- Regulatory & Compliance Support

• Comprehensive guidance on MDR 2017/745 and IVDR 2017/746 regulations
• Risk classification and market access strategy
• Provision of an EU Authorized Representative
• EUDAMED registration and communication with competent authorities and Notified Bodies

🔗 European Commission, official website – European Commission

2- CE Certification & Technical Documentation

Technical Documentation
• Gap analysis and document alignment with CE requirements
• Coordination with Notified Bodies throughout the process

🔗 /ce-certification-services

3- Quality Management Systems (QMS – ISO 13485)

• Preparation of Technical Documentation files
• Gap analysis and document alignment with CE requirements
• Coordination with Notified Bodies throughout the process

🔗 ISO 13485:2016 – Medical devices — Quality management systems — Requirements for regulatory purposes

4- Specialized Training Programs

• Professional training in MDR, IVDR, ISO 13485
• Audit and inspection readiness
• Custom training courses tailored to your company

🔗 /training-courses

5- Market Development & Distribution Network Setup

• Target market and competitor analysis
• Identification of qualified distributors
• Professional international negotiation support

🔗 Medica Trade Fair – Distributors & Trends

6- Medical Equipment Procurement Consulting

• Selection of trusted brands for clinics and institutions
• Price and technical feature comparisons

7- Exclusive Brand Representation

• Drafting and negotiation of official distribution agreements
• Legal review of contracts
• Ensuring compliance with CE and international standards

🎯 Why Choose Us?

✔ Trusted by dozens of international companies
✔ Practical and cost-effective solutions
✔ Consulting based on up-to-date European regulations
✔ Insightful, data-driven reporting and analysis

📞 Request a Free Consultation

To receive a free initial consultation, please fill out the contact form on our Contact Us page or email us directly.