- To ensure that our medical device manufacturers can produce products in compliance with national and international standards, regulations, legislation, and guidelines,
To provide rapid, practical, effective, and sustainable solutions in line with national and international standards, regulations, legislation, and guidelines, for any issues and obstacles manufacturers may encounter in the ISO 13485 Quality Management System and 2017/745/EU Medical Device Regulation (MDR) marking/certification processes, as well as ensuring the continuity of these certifications,
To continuously support medical device manufacturers with a commitment to compliance with evolving standards, regulations, and guidelines, and a focus on continuous improvement,
To ensure that manufacturers are prepared not only for audits by Notified Bodies but also for planned or unannounced field inspections or market surveillance that may be conducted by the Ministry of Health of the Republic of Turkey.
Our Quality Objectivesadmin2024-12-04T02:00:23+03:00