Umut Doğu Seçkin

Research and Development Process, Regulatory Requirements and Clinical Trial of Medical Devices: A Review within the Framework of the Turkish Medicines and Medical Devices Agency (TITCK) and the European Union (Regulation 2017/745)

Medical devices encompass a wide range, from simple instruments to complex implants and software, and recent technological advancements have significantly increased both their number and clinical significance. Bringing a medical device from concept to clinical use requires an integrated pathway combining structured res...