EU Technical File Preparation
Technical File Review
MDD/MDR Gap Analysis
Managing relations with NBs
Quality Management System
Establishing QMS ISO 13485
Improving/updating the current QMS System
Access to Turkish Market
Product Registration & MoH Approval
Selecting most suitable reimbursement code
Defining Sales Strategy
Support in Market Penetration and Product Launch
Assisting foreign companies in procurement from Turkey
Helping Turkish companies to place their products into foreign markets
With our solution partners , we offer comprehensive and specialist service to medical device manufacturers. Our team members are former employees of Notified Bodies, former medical device auditors, product specialists and MBA holder commercial managers with many years experience in the medical technologies.
More than 10 years we have prepared countless of technical files in different medical device groups such as orthopaedic – spinal implants, bone grafts, wound care products, opthalmic implants and devices, cardiovascular implants and devices, various disposable medical products; established and revised QMS and helped foreign manufacturers in product launch in Turkish Market.
You are in safe hands with us.