I provide comprehensive consultancy services for the medical device sector, specializing in CE certification processes, technical file preparation, clinical evaluation reports, product and process risk analysis, as well as PMS and PMCF studies. With expertise in ISO 13485 and MDR (2017/745) requirements, I guide companies to ensure compliance with national and international regulations. Leveraging my academic and industry experience in health technologies, I support medical device manufacturers in developing innovative solutions and quality management systems.Tıbbi cihaz sektörü için kapsamlı danışmanlık hizmetleri sunuyorum. CE belgelendirme sürecinde, teknik dosya hazırlığı, klinik değerlendirme raporları, süreç ve ürün risk analizleri, PMS ve PMCF çalışmaları gibi kilit alanlarda uzmanım. ISO 13485 ve MDR (2017/745) gereklilikleri doğrultusunda firmalara yol gösteriyor, ürünlerin ulusal ve uluslararası mevzuatlara uyumunu sağlıyorum. Sağlık teknolojileri alanındaki akademik ve sektörel deneyimimle, tıbbi cihaz üreticilerine inovatif çözümler ve kalite yönetim sistemleri geliştirme konularında destek veriyorum

• Providing training on medical device regulations (2017/745 and 2017/746).• Preparation of Class Is-m-r, Class IIa, Class IIb and Class III technical files within the scope of the medical device regulation (2017/745 and 2017/746)• Process and product specific risk analysis (ISO 31001 and ISO 14971)• Preparation of product-specific clinical evaluation report and management of PMS-PMCF-PSUR processes and preparation of reports• Documenting the clean room and sterilization process

• Documentation and vitality of the quality management system established for manual and/or electric breast pumps to be used in medical fields• Managing the technical file processes for the relevant product• Follow-up of product-specific performance tests (IEC 60601 series)

• New product design and R&D studies• Licensing of antiseptic, disinfectant, medical device disinfectants and cleaning products for use in medical fields and management of CE marking processes• Preparation and vitality of the system's documents created in accordance with ISO 9001:2008, TS EN ISO 13485:2012, ISO 22716: 2013 TS EN ISO 14001: 2015, TS 18001: 2014 • Preparation of documents of technical file components by scanning the literature and reviewing equivalent product data• Performing risk analysis for the process and product• Making product records and following the process in the Biocidal Product Tracking System

• New product design and R&D studies• Licensing of antiseptic, disinfectant, medical device disinfectants and cleaning products for use in medical fields and management of CE marking processes• Preparation and vitality of the system's documents created in accordance with ISO 9001:2008, TS EN ISO 13485:2012, ISO 22716: 2013 TS EN ISO 14001: 2015, TS 18001: 2014 • Preparation of documents of technical file components by scanning the literature and reviewing equivalent product data• Performing risk analysis for the process and product• Making product records and following the process in the Biocidal Product Tracking System

• Management of the production process for encapsulated omaga3, glucosamine and l-carnitine products from food additives (Preparation of mixture, encapsulation and packaging for related products)• Marketing of products to pharmacies through pharmaceutical warehouses