Medical device manufacturers are experiencing difficulties in the sector where competition is increasingly heated. Today, these companies are required to meet the quality-related requirements and to perform regulatory and preventive actions before putting their products on the market. On the other hand, it is important to act quickly in the introduction of new medical devices. You need to be fast to maintain competition and be in front of competitors.
ISO 9001 Quality Management System ISO 13485 Quality Management System for Medical Device Manufacturersis an international quality management system covering special conditions for medical devices. Producer companies, distributors, importers and exporters working in the production or supply of medical devices can establish ISO 13485 Quality Management System for Medical Device Manufacturers in their enterprises in accordance with the legal regulations and in accordance with the Quality Management System. This standard can also be used in the CE marking system of medical device manufacturers.
This standard, which is based on the process approach model in general, is aimed at the companies operating in the trade and manufacturing of medical devices. It can be applied to all companies which include the design, production, installation and supply stages of medical devices or related services. It is possible to ensure that medical devices are healthy and safe and provide minimum conditions. It is a very important guide in terms of the sterilization and hygiene characteristics of these devices.
Organizations that establish and manage the Quality Management System for ISO 13485 Medical Device Manufacturers have significant benefits. For example, they gain competitive advantage, whether in domestic markets or in global markets. As the processes are clarified and documented, production errors are overcome. The system's deficiencies are easier to see and more rapid intervention is possible. This naturally lowers costs and increases productivity. As the quality of the product or service offered will increase, trust is created in the eyes of consumers.
The Ministry of Health is obliged to have the ISO 13485 Medical Device Manufacturers Quality Management System Certificate for the manufacturers and importers in our country for the medical devices with CE marking by issuing a declaration of conformity only.
Companies that have to comply with the legal regulations, on the other hand, must comply with the requirements of this system in order to achieve competitive advantage.
Companies producing or supplying medical devices to meet current legal requirements, to increase customer satisfaction, to increase firm efficiency and to obtain legal assurance against possible lawsuits, ISO 13485 Quality Management System Certificate for Medical Device Manufacturerswants to have.
Companies that want to provide the design, development, production, installation and after-sales services of medical devices with a quality management system approach and who want to prove the ability of customers to meet the expectations of medical devices can request ISO 13485 Quality Management System Certificate for Medical Device Manufacturers. it is necessary to apply to the certification body. Medical devices are often complex high-risk products, and inspection and inspection of these products requires expertise.
Medical device production, TURCERT certification bodyis also an issue on which it provides both certification studies and consultancy and training services. The TURCERT certification body Medical Devices - Quality Management System can be grouped under the following headings:
- TS EN ISO 13485 Medical Devices - Quality Management System Training
- TS EN ISO 13485 Medical Devices - Documentation Training
TS EN ISO 13485 Medical Devices - Quality Management System TrainingTo inform the participants about the design, development, production, establishment of the medical devices and the frame of the services to be provided. This training program covers TSE certification procedure, basic concepts related to quality, organization structure in quality management systems, introduction of ISO 13485 standard, interpretation of the clauses of this standard and so on.
TS EN ISO 13485 Medical Devices - Documentation TrainingQuality Policy, Quality Objectives, Quality Manual, which are required to be prepared during the establishment of this system, the processes foreseen by the standard and the preparation methods of the support documents to ensure the implementation and supervision of these processes are given. This training program covers document structure of quality management systems, Quality Manual, processes, application instructions, forms, charts, needed documents, case studies and so on.