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ISO 13485:2003

ISO 13485, a standard that defines the specific requirements that quality systems for organizations operating in the field of medical device trade and manufacturing must meet, can be applied by all organizations involved in the project, production, installation and supply phases of medical devices or services related thereto.

  • The products shall be able to demonstrate their health, safety and safety features and to meet minimum requirements with EN ISO 13485 certification and CE marking studies.
  • It is a partnership with the European Union and other countries in the manufacture, sale and service of medical devices.
  • It is closely related to CE Marking of medical devices.
  • Sterilization and hygiene are very important guides.
  • Special requirements apply for sterile medical devices.
  • A guideline for identifying risk groups of medical devices.

WHAT ARE THE BENEFITS OF THE ISO 13485 QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES?

  • Training enables continuous improvement and development.
  • It is one of the most important tools for increasing quality consciousness in companies.
  • It allows the design, production and service levels of medical devices to be increased.
  • It makes it easy to comply with laws and regulations.

WHO CAN USE / IMPLEMENT ISO 13485 STANDARD?

The ISO 13485 Quality Management System Standard for Medical Devices can be applied to all institutions and organizations that continue to work in the production and service activities of all products covered by the medical device.