ISO 13485 Medical Devices Quality Management System is a standard designed for companies that produce medical devices and provide technical support services to promote and market their products not only in national markets but also in international markets globally. In this context, the popularity of these medical devices in European Union countries depends on their compliance with the European Union directives. In the transition process to the European Union, our country, for example, must comply with the directives for implantable medical devices, the medical devices directive, the in vitro diagnostic directive and similar directives, and make its own internal legislation and directives compatible. In this respect, the Ministry of Health issued the Medical Device Regulation in 2007, the In Vitro Medical Diagnostic Devices Regulation in the same year, and the Regulation on the Implantable Active Medical Devices in 2011.
The medical device manufacturers which are manufactured in our country and wanted to have free circulation abroad, have established ISO 13485 Medical Devices Quality Management System and applied to an independent and accredited certification institution after a while. ISO 13485 Certificate demand.
Nowadays ISO 13485 standard It has become a sought-after standard not only for European Union countries but also for any country in the world. This standard is applicable to all companies providing design, production, assembly and installation of medical devices and technical support services after installation.
In addition, ISO 13485 Medical Devices Quality Management System is preferred by all companies that want to keep their production and service processes under control. Because of this standard, compliance with the norms of the European Union and our own legal regulations are ensured, it is possible to produce safer medical devices, thereby increasing the trust in the company and achieving success in sales and marketing.
It is important for the company that manufactures and service medical devices to be successful, to grow and survive successfully, to be systematic and transparent, to make work processes traceable and controllable.
During the establishment of ISO 13485 Medical Devices Quality Management System, firstly the current situation should be analyzed, risk assessment studies should be done, critical control points should be determined and processes should be determined. after that, standard trainings will be taken, a working team will be established, strategies will be determined, quality manual will be prepared, implementation procedures will be established and the system will be implemented. The next step is to apply to an accredited certification body and start certification studies.
our company TÜRCERT Technical Control and Certification provides fast, high quality and reliable consultancy services to all medical device manufacturers who want to establish ISO 13485 Medical Devices Quality Management System and have ISO 13485 Certificate. If you have any doubts about what ISO 13485 Medical Devices Quality Management System is and what it does, we are always with you as a company.