Boğaziçi University Center for Targeted Therapy Technologies (Boğaziçi CT³) established the Medical Device Development (MDD) Unit Cleanrooms to enable the development of microsystem-based medical devices—ever more widely used in healthcare—that enter and/or are implanted in the human body, and to support the fabrication of clinical-grade prototypes. The facility comprises five validated cleanrooms compliant with international ISO 14644 standards, meeting ISO Class 5, ISO Class 6, ISO Class 7, ISO Class 8, and ISO Class 7 GMP (Good Manufacturing Practices) requirements.

Examples of devices that can be developed and manufactured in these cleanrooms include next-generation endovascular catheters, guidewires, implantable smart sensors, electrical stimulators, and implantable systems that release drugs in a controlled manner only when needed.

The MDD Cleanroom provides users not only with the capability to mechanically assemble endovascular catheters from basic materials using plastic and metal support units, but also with an infrastructure that enables the integration of optical, electronic, and mechanical microsystems into these catheters. In addition to these activities, the cleanroom is also open to researchers from other disciplines for MEMS and other microdevice studies.

Our MDD Cleanroom Unit obtained ISO 13485:2016 Quality Management System (QMS) certification in 2019 to support the medical device industry in critical intermediate processing steps and to serve as a sub-supplier. This accreditation was renewed in 2025.

With its ISO 13485:2016 certification, the Medical Device Development Cleanroom Unit enables prototypes prepared under this framework to be directly tested in the human body. Moreover, our ISO 7 / GMP (Good Manufacturing Practices) cleanroom infrastructure—among publicly available service facilities—has passed the infrastructure audit required for an FDA (Food and Drug Administration) certificate issued by the office of the United States Department of Health and Human Services responsible for food, dietary supplements, pharmaceuticals, biological medical products, blood products, medical devices, radiation-emitting products, veterinary products, and cosmetics, and has been deemed suitable in terms of manufacturing capability.

For detailed information and service requests, please contact us: [email protected]