Within the framework of the New Approach prepared by 1985, the European Union has started CE marking system as a safety and health mark on the products. Products bearing CE marking are considered healthy and safe for human, animal and environmental conditions. The CE mark indicates that any product is designed and manufactured in accordance with European standards.
The main objective of ISO 13485 Medical Devices Quality Management System is to ensure that the health and safety conditions of the companies are maintained at a high level, that production and service in accordance with the principles of security and technology are reached and that the clinical environments and patients' safety is not affected negatively. It is also the main objective of the system to ensure that the performance foreseen for products and services is achieved, that the intended use is not adversely affected during transport and storage, and that the risks arising from unexpected side effects are kept at an acceptable level.
However, in addition to these main objectives, an objective of ISO 13485 CE marking to lay the groundwork for medical device manufacturers who want to The CE marking system is a system established by the European Union to ensure the free movement of products. In practice, for the CE marking system, ISO 13485 Medical Devices Quality Management System has been established in the company. Medical device manufacturers which have established ISO 13845 standard can easily put CE mark on their products.
Within the scope of the European Union New Approach directives, medical devices are included in the product groups that require CE marking. The European Union directives on the medical sector are as follows:
- 93 / 42 / EEC Directive: Medical Devices
- 98 / 79 / EC Directive: In Vitro Diagnostic Medical Devices
- 90 / 385 / EEC Directive: Active Implantable Medical Devices
Within the framework of these directives, first of all, it should be clarified whether the products have CE marking and which directive they are covered by. If there is no hesitation in this regard, the company should have established and implemented ISO 13485 Medical Devices Quality Management System and obtained ISO 13485 Certificate.
However, even if the medical device manufacturers do not get CE Certificate, if they want to provide a standardization in their production and service activities, if they want to improve the design, production and service quality of their products, to harmonize with the global world, and to increase the trust in their products, especially if they want to be strong in exports to European Union countries and if it wants to improve the product quality, to gain competitive advantage in the sector and to increase the prestige and prestige of the company in the market, ISO 13485 Certificate must take.
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. You can immediately apply to our company managers and employees to exchange opinions about whether medical companies are required to obtain ISO 13485 Certificate.