Integrated Logistics, Customs and Trade Harmonization
MEDICAL PRODUCT CERTIFICATION AND GLOBAL LICENSING
Strategic Framework: The healthcare industry is subject to the most stringent global regulations due to its
direct impact on human health. From product design to end-user delivery, the entire lifecycle demands a
flawlessly operating Quality Management System and absolute conformity with international standards. This
service encompasses the process of obtaining the technical and regulatory passport that ensures your product
is not only manufacturable but also marketable and freely tradable in global markets.
Management Phases
Medical Product Certification and Global Regulatory
Quality Management System Implementation (QMS - ISO 13485)
The ISO 13485 standard, which constitutes the foundational framework for medical manufacturing, is integrated into the company's operational DNA. Certification infrastructure, risk management procedures, and production tracking systems are established to create an auditable quality ecosystem..
Technical File, MDR Compliance and CE Marking
This phase covers the preparation of technical documentation in full compliance with the European Union Medical Device Regulation (MDR). Clinical evaluation reports, biocompatibility testing, and risk analyses are managed, and CE certification is pursued through Notified Bodies, enabling free circulation within the European market.
National and International Registrations (UTS / EUDAMED)
These constitute digital traceability systems. Products are registered in Turkey's Ministry of Health Product Tracking System (UTS) and Europe's EUDAMED database, ensuring global product identity and traceability.
Why is it critical?
In the medical sector, certification is not a quality label but a market prerequisite. A product with incomplete or erroneous documentation, regardless of its innovative merit, cannot clear customs or be sold to healthcare institutions. Particularly with the increasing stringency of MDR requirements, procedures have become a formidable barrier for manufacturers lacking technical competence. A flawed application strategy can prolong processes for years, result in the loss of market access, and render millions of dollars in factory investment virtually stranded.
ARC Approach
ARC Strategic Consulting's approach in this domain extends far beyond textbook knowledge. We possess a technical lineage rooted in the production and export of dialysis filters—one of the most sensitive product categories in the healthcare industry. We are a team that has gained experiential knowledge of technical file preparation and auditor scrutiny not at the desk but on the ground and in the laboratory. We manage the investor's certification process end-to-end, encompassing not merely documentation but the full commercial lifecycle of the product.
Telephone: 0 (216) 321 37 28
+90 530 492 21 37
Email: info@arcglobal.tr
Address: ARC Global Consulting and Foreign Trade Ltd. Co. İnkilap Mah. Küçüksu Cad. No: 109/C Floor: 1 No: 3 Ümraniye Istanbul