Our country, which continues its harmonization with the European Union, has issued regulations based on three directives on medical devices in the European Union. The aforementioned regulations issued by the Ministry of Health are:
• Medical Device Regulation (published in 2007)
• In Vitro (Used Outside Body) Medical Diagnostic Devices Regulation (published in 2007)
• Implementing Regulation on Implantable Active Medical Devices (published in 2011)
These regulations include definitions of various medical devices, compliance with harmonized standards, protection measures, classification procedures, conformity assessment procedures, special methods for sterilization, principles for CE marking system, basic requirements, supply and service to the market and principles for free movement.
ISO 13485. Medical Devices Quality Management System This standard covers all manufacturers producing medical devices as defined in these regulations and providing technical support services for these devices.
By applying ISO 13845 standard and obtaining ISO 13485 Certificate, these companies maintain high level of health and safety conditions in their products and produce and serve in accordance with the principles of safety and using the latest technologies. Thanks to this standard, it is able to achieve the expected performance for its products and services.
The clinical environments and patients are safe when these medical devices are used. In addition, risks that may arise due to unexpected side effects are kept at an acceptable level. When storing or transporting medical devices to the place of use, the intended use methods are also prevented from being adversely affected.
With the ISO 13485 Medical Devices Quality Management System Certificate, manufacturers have proven that they produce medical devices in accordance with customer needs and expectations and that they provide services related to these devices and that they are able to meet the conditions required by European Union norms and national legal regulations. In short, the main purpose of the ISO 13485 standard is to facilitate the requirements of medical devices legislation that is in line with quality standards.
The ability of companies producing medical devices to carry out commercial activities with all other countries, particularly the European Union and Canada, depends on establishing a system in accordance with ISO 13485 standard. Once this standard has been established and applied for a while, the ISO 13485 Certificate must be obtained from an accredited certification body.
In this way, the manufacturing companies will gain prestige and reputation in the markets and gain a great advantage in the competitive conditions.
All medical device manufacturers who want to establish ISO 13485 Medical Devices Quality Management System and have ISO 13485 Certificate, TÜRCERT Technical Control and Certification company, they will receive a fast, quality and reliable consulting service. As with all management systems, you can immediately apply to our company managers and employees to exchange opinions on ISO 13485 Medical Devices Quality Management System.