On November 18, 2014, "Biocompatibility and Biomaterials Workshop" was organized for the Medical Devices and Materials Sector with the participation of Chemical Technology, Materials and Food Institutes under the coordination of TUBITAK Marmara Research Center Gene Engineering and Biotechnology Institute.
During the workshop, companies representing the sector were informed about the legislation, R&D project supports and test/analysis services within the scope of the medical devices and materials sector, current problems were discussed, and opinions and suggestions were shared. Following the opening speech of Prof. Dr. Şaban TEKİN, Director of the Institute of Gene Engineering and Biotechnology, Seçil Selçuk, Business Development Unit Manager, gave information about the infrastructures and research potentials of TÜBİTAK MAM and related institutes for the target sector. In line with the purpose and scope of the workshop, Mr. Ali BOZDOĞAN from the Medical Device Registration Unit of the Ministry of Health informed the participating company representatives about the "Medical Device Legislation and T.R. Pharmaceuticals and Medical Devices National Information Bank (TİTUBB) Applications" in our country with his presentation. The second important issue other than compliance with the legislation in terms of the introduction and commercialization of the developed products to the domestic and foreign markets is to ensure CE certification conditions. In this context, Mr. Fevzi GÜLÜNAY, representative of Kiwa Meyer CE certification institution, provided important information to the company officials about the CE certification process with his presentation titled "Problems and Solutions in the Evaluation of Medical Devices".
"Biocompatibility Tests", which constitute an important stage in ensuring the licensing and certification conditions of medical devices and materials, was another topic of the workshop. In this context, Dr. Yüksel ÇETİN, who works as an Expert Researcher at the Institute of Gene Engineering and Biotechnology, gave information about the market share of medical technology in the world and in Turkey, Risk Assessment and Management of Medical Devices in his presentation titled "ISO 10993 - Biocompatibility Tests of Medical Devices".
She also explained the categories of Medical Devices according to their contact and duration of stay in the biological system and the Biocompatibility Tests and sample preparation standards to determine the effects accordingly. Finally, Ms. Ümran ELMAS from TÜBİTAK TEYDEB made a presentation titled "TÜBİTAK-TEYDEB Grant Supports in the Medical Devices Sector" to provide information about the project programs that companies can benefit from in order to realize their product development / improvement ideas.
With this workshop, all main topics from product development to commercialization, project supports, test/analysis services and legislation in the Medical Device and Material Sector were tried to be addressed. The discussion of the problems and unknown points of the Medical Device and Material Manufacturers during the CE Certification phase, as well as the CE Certification representatives' voicing of the issues to be followed and paid attention to during the process, in addition to the legislation and licensing requirements of the Pharmaceuticals and Medical Devices Agency, which is in the last process, provided the participating members with a general perspective on the subject. As an institution, a valuable gain was also achieved in terms of developing/improving the test analysis services carried out within the scope of ISO 10993 and creating new collaborations with companies representing the sector by creating project partnerships.
Contact and detailed information : soner.aksu@tubitak.gov.tr
