The main objective of the companies that establish and implement the ISO 13485 Medical Devices Quality Management System in their enterprises and obtain the ISO 13485 Certificate, is in compliance with the European Union harmonization laws and other legal regulations in the medical device manufacturing and technical support activities.

ISO 13485 standardhas been designed to be applicable regardless of size, production capacity and number of employees. Medical device manufacturers can establish and apply ISO 13485 standard in their enterprises in accordance with the current legal regulations and the conditions required by European Union norms.

In 2007, the Medical Device Regulation was issued by the Ministry of Health. In this regulation, medical devices are defined as follows: Medical devices are those devices which, when used on human beings, do not fulfill their essential function by pharmacological, immunological or metabolic effects, but which may be supplemented by these effects in their function.

Again, according to the regulation, the use of medical devices on humans can only be used for the following purposes:

  • Diagnose, prevent, monitor, treat or reduce the effects of a disease
  • Diagnose, monitor, treat, mitigate or relieve victims of injury or disability
  • Investigate, alter or replace an anatomical or physiological function
  • Contraception in women or taking medication only

The companies which produce all the medical devices used for these purposes and provide technical support services for these devices can establish ISO 13485 Medical Devices Quality Management System and obtain ISO 13485 Certificate in their enterprises.

The benefits of these companies from having ISO 13485 Certificate are as follows:

•      To provide standardization in production and service activities

•      To improve the design, production and service quality of medical devices

•      In this way, to adapt to the global world

•      To strengthen its hand in exports especially to European Union countries

•      To adopt a process-oriented approach

•      To complete the documentation related to production and service activities

•      Raising quality awareness in company employees

•      To gain competitive advantage in the sector

•      To increase the prestige and prestige of the company in the market

•      Increased confidence in medical devices manufactured

•      To show the importance given to human health by raising product quality

•      Facilitate compliance with relevant regulations

Considering that the ISO 13485 standard aims to improve the design and development processes of medical or medical devices, to meet customer needs and expectations, to comply with the legal regulations on medical devices and to continuously improve on all of these issues, the benefits described above are big gains for companies producing medical devices. means.

 

our company TÜRCERT Technical Control and Certification The company provides fast, high quality and reliable consultancy services to all medical device manufacturers who want to establish ISO 13485 Medical Devices Quality Management System and have ISO 13485 Certificate in their companies. ISO 13485 Medical Devices Quality Management System If you have any doubts about the benefits of the Certificate, we are always there for you.