The ISO 13485 Medical Devices Quality Management System is a standard parallel to the ISO 9001 Quality Management System and is based on the ISO 9001 Quality Management System Standard. It is the form of ISO 9001 Quality Management System Standard adapted to and developed for medical devices. It is an international standard that includes special requirements for medical devices.

The ISO 13485 Medical Devices Quality Management System is one of the most important arguments that medical device manufacturers can use when going to CE Marking. It is a necessary system to set up companies if the production quality assurance module is selected within the scope of CE Marking. It is based on the ISO 9001 Quality Management System, and has been made a standard for manufacturers of medical devices with additional requirements for the design stage and specific conditions for sterile medical devices in particular.

This standard, which is based on the ISO 9001 Quality Management System process approach model, contains more comprehensive and specific quality system requirements than ISO 9001 and must be met by establishments who wish to provide medical devices and related services and want to prove their ability to meet customer and regulatory requirements applicable to medical devices in a consistent manner.

Who Requires the ISO 13485 Medical Devices Quality Management System?

Businesses carrying out manufacturing in the medical field are required set up and apply the ISO 13485 Medical Devices Quality Management System and also need to document this with the ISO 13485 Certificate. In accordance with Turkey's European Union legislations, the manufacturers of medical devices in Turkey are obliged to carry out studies on European medical device directives, i.e. CE product marking.

Benefits of ISO 13485 Medical Devices Quality Management Application

• Provides a competitive advantage.

• Increases awareness of quality among employees

• Adoption of a process-oriented approach

• Creation of documentation (infrastructure) to ensure standardization of business activities

• Increases the reputation of the establishment in the market

• Ensures global compliance of medical devices to quality standards

• Increases the quality of design, production, and service of medical devices

• The advantage of exporting to European Union countries in particular is provided

• Increase in confidence in devices

• Protection of human health based on the increase in the quality of the devices

• Facilitation of compliance to various laws and regulations related to this topic