The Medical Device Development or Clean Room Unit has the necessary infrastructure for the development and production of clinical quality prototypes of microsystem-based medical devices that are increasingly used in the field of health, entering and/or implanting in the human body. MEMS and other micro-device studies are also carried out in the unit. ISO 13485 certification was obtained in 2019 to support the medical device industry in critical intermediate product processing stages. In 2022, this accreditation was updated. The Medical Device Development Unit allows the prototype, which was prepared with ISO 13485 certification, to be tested directly on the human body.
Boğaziçi University Biomedical Engineering Institute Cleanroom
BME Temizoda was established within the body of Boğaziçi University Life Sciences and Technologies Application and Research Center in order to carry out studies on the production of clinical quality prototypes of microsystem-based medical devices that are increasingly used in the field of health, entering and/or implanting in the human body. New generation endovascular catheters, guide wires and smart sensors implanted in the body, electrical stimuli and in-body systems that release drugs in a controlled manner only when necessary can be given as examples of devices to be developed and produced in the cleanroom. BME Temizoda does not only mechanically assemble endovascular catheters made of plastic and metal support units from basic materials, but also insert optical, It provides an infrastructure that will make it possible to integrate electronic and mechanical microsystems to its users. In addition to these studies, the laboratory is open to researchers from other branches for MEMS and other micro-device studies.
