ADVANCING CARDIAC CARE • GLOBAL STRATEGIC ALLIANCES • CLINICAL EXCELLENCE • CORCELL SYSTEMS •
08 · Regulatory & QMS
A Proven, Audit-Ready Compliance Engine
We Will Not Be Learning Turkish IVD Regulation on iLine’s Time.
CorCell Medical operates within Turkish medical device and IVD regulation daily, with established infrastructure for TITCK UBB registration, Turkish labelling, SGK SUT coding, DMO tender eligibility, vigilance, post-market surveillance and ISO 13485:2016-aligned quality management.
01
CE Mark Acceptance
CE/IVDR equivalence accepted by TITCK as primary regulatory basis.
02
TITCK UBB Registration
CorCell as importer files technical file + CE declaration + TR labelling.
03
Turkish Labelling
All IFUs / software / packaging localized under our auth-rep mandate.
04
SGK SUT Coding
Chapter 9 IVD reimbursement application — established POC INR precedent.
05
DMO Tender Eligibility
Public-hospital centralized procurement access — highest-volume channel.
ISO 13485:2016
Quality Management System for Medical Devices — full distributor scope.
TITCK Authorisation
Medical Device Sales & Service Center Certificate (Tıbbi Cihaz Satış Merkezi Yetki Belgesi).
Vigilance & PMS
Post-market surveillance, complaints handling and incident reporting workflow — TITCK aligned.
Data & Documentation
Controlled-document system; full audit trail for tender and reimbursement files.
CorCell Medical | Regulatory & QMS Profile | Confidential Audit-Ready Data