Official Company & Facility Registration: End-to-end legal registration and onboarding of manufacturers, importers, or distributors before the Turkish Ministry of Health and TİTCK systems.

MDR Regulatory Compliance & Classification: Thorough assessment under the Medical Device Regulation (MDR) to determine accurate classifications (device, system, or procedure pack) and regulatory pathways.

Technical Documentation & Certificate Management: Comprehensive verification of CE certificates, declarations of conformity, and technical files, including legal translation, notary processing, and system lodging.

Turnkey ÜTS Product Notification & Approval: Fact-checking product data, managing data entry into the Product Tracking System (ÜTS), driving approvals, and designing customized, compliant product labels in PDF format.

Pricing & SUT (Healthcare Reimbursement) Mapping: Strategic handling of product pricing entries and precise mapping against SUT codes to ensure regulatory alignment.

SGK (Social Security) Reimbursement Registration: Comprehensive registration, renewal, and maintenance of product portfolios within the SGK (MEDULA) reimbursement databases.

Free Sale Certificate (FSC) Sourcing: Streamlining TİTCK applications to secure Free Sale Certificates for domestic productions or re-exported medical devices entering global markets.

Cosmetics & Biocidal Product Notifications: Managing compliant market launch strategies, notifications, and registration frameworks for cosmetics and biocidal products.

EKAP (Government Tender Platform) Management: Official registration on the Electronic Public Procurement Platform (EKAP), managing Authorized Tender Representative roles, and securing tender compliance.

TOBB-GS1 Turkey Barcode & GTIN Operations: Handling corporate GS1 Turkey memberships, global barcode/GTIN allocations, and seamless ÜTS data synchronization.