ISO 13485 - QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES
ISO 13485 is an international standard based on the TS-EN-ISO 9001:2000 standard, which includes special requirements for medical devices. It is a management system designed to meet current legal obligations for medical device manufacturers, ensure continuity of customer satisfaction, increase internal efficiency and create legal assurance against lawsuits that may be filed as a result of possible customer complaints.
Quality management systems help an organization achieve its quality policy and objectives. ISO 13485 is a quality management standard for organizations operating in the medical device industry. This standard focuses on the design, manufacture, and distribution of medical devices to ensure product safety and effectiveness.
Kaliteturk Consulting provides professional consultancy services to organizations in the process of implementing the ISO 13485 standard. Fulfilling the requirements of ISO 13485 is of great importance for the safety and effectiveness of medical devices. Kaliteturk Consulting experts ensure the effective implementation of the ISO 13485 quality management system .
It was created to structure the organizations that provide these services. ISO 13485 is compatible with the EU Medical Devices Directive and requires the use of the CE mark in Europe and in our country since 2003. Therefore, it is applied together with the CE mark.
ISO 13485 certification is an essential need for medical device manufacturers who plan to operate in the international market. Kaliteturk Consulting has the experience and knowledge to help you obtain this certification and implement this standard.
In the medical device industry, where quality is important, it is a must to meet the requirements of ISO 13485. By cooperating with Kaliteturk Consulting, you can meet the requirements of this standard and gain the competitive advantage in your industry.