For companies producing medical devices and providing technical support services related to these, it is very important to observe the following principles during their activities:
- High protection of health and safety conditions
- Production and service in accordance with the safety principles and at the level of technology
- Achieving predicted performance for production and services
- Clinical environments and safety of patients is not adversely affected
- During transport and storage of products, the intended use is not adversely affected
- Keeping the risks that may arise from unexpected side effects at an acceptable level
ISO 13485. Medical Devices Quality Management System is first of all a quality standard and the products and services offered must comply with the quality standards. However, since medical devices have their own specific functions, the ISO 9001 standard, which is based on the ISO 13485 Quality Management System standard, has the additional requirements listed above. In addition to these basic requirements, the standard also has other requirements. For example, chemical, physical and biological properties, infection and microbial contamination, production and environmental characteristics, devices with measurement function, radiation protection, devices connected to an energy source, devices with an energy source on itself.
Companies that establish ISO 13485 Medical Devices Quality Management System and apply it for a period of time apply to a certification institution when they are ready and ISO 13485 Certificate demand. The most important issue to be considered at this point is whether this certification body is accredited or not. The institutions that generally authorize this issue are TÜRKAK (Turkish Accreditation Agency) in our country, FDA in the USA, CMDCAS in Canada, JPAL in Japan, ZLG and ZLS in Germany, and MDCO in Hong Kong. In order for the ISO 13485 Certificate to be valid, the certification body must be authorized by one of these national or international accreditation bodies.
Of course, certification bodies are commercial entities and will charge a fee. However, the selection of the certification body should not focus solely on the price. Otherwise, a proper service cannot be obtained and the document to be issued has no validity.
To provide standardization in production and service activities, to improve the design, production and service quality of medical devices, to harmonize with the global world in this way, to strengthen its hand in exports to European Union countries in particular, to increase the confidence in its products, to show the importance given to human health by raising product quality, competition in the sector ISO 13485 Certificate is required for all companies that want to gain advantage and increase the prestige and prestige of the company in the market.
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 contact our company managers and employees to discuss how to obtain the most appropriate ISO 13485 Certificate.