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Legal  Registration Holder services to  the commercialization of your device in Turkey.

Registration Holder is responsible for registering your device to MoH and responsible for all events related to medical device. As LRH of your company, we will authorize other companies as approved distributors of your registered products. Our expertise will ensure you performance in sales without risk of restrictive distributorship agreements, avoid conflicts between distributors and provide representation as your regulatory representation to MoH.


Assistance with medical device registration and medical device approval.

  • Preparation of all application documents.
  • Coordination of documentation translation into Turkish
  • Submission of all registration documents through the Turkish Pharmaceutical and Medical Device National Databank (TITUBB)
  • Independent authorized representation as your regulatory liaison in Turkey
  • Guidance on the appropriate reimbursement code selection
  • Managing  audits of your device, if necessary.


Benchmark Testing, Preclinical Data and Clinical Trial Management for Medical Devices*

We will provide you services for necessary data for demonstrating safety and effectiveness of your medical devices* required to complete your risk analysis and approvals.

  • Demonstrating the biomechanical safety and biocompatibility of a medical device.
  • Demonstrating the clinical safety and effectiveness of a medical device for Competent Authority Approval.
  • Obtaining post-market surveillance clinical data on devices with CE Marking.
  • Obtaining health economic data to support obtaining reimbursement approvals.
  • Reporting and anaysing the study data.

*Services are limited to type and area of use for Medical Devices covered under MDD 93/42/EEC.  



ISO 13485 Consulting

We will constitude and customize your ISO 13485 quality system to meet specific needs, and make sure you are ready for a certification audit.

  • ISO 13485 documentation based on essential regirements and your system needs.
  • On site employee training
  • Technical file constitution for medical devices
  • Internal and supplier audit support
  • Assistance and recommendation of certified OEM suppliers, third-party testing and certification firms that specialize in your category of devices.

Patent Consulting

We provide consultancy services throughout the entire patenting process from the strategic analysis of the business potential to the drafting and prosecution of your patent application. 

We guide you the process to register your patent in Turkey.



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