ISO 13485 is intended for organizations that develop, manufacture, install, distribute, or provide service for a medical device.
The standard details the quality management system requirements of medical device manufacturers in order to provide products that are safe to use and apply with the regulatory requirements of international bodies such as CE, FDA, TGA, etc. The standard is set by the International Organization for Standardization.
When marketing a medical device in the European Union, the product must comply with the requirements of the European Directives for medical devices and must bear the CE mark issued by Notified Bodies, which have been certified by the health authorities in the EU countries. In the product approval process, the manufacturer must prepare a technical file of the product and quality system to prove that the manufacturer and product do indeed meet the requirements for obtaining the CE mark.
In addition, when marketing a medical device in the United States, the product must meet the FDA requirements and be approved by the FDA. In the product approval process, the manufacturer must prepare a technical file of the product and quality system to prove that the manufacturer and product do indeed meet the requirements for obtaining FDA approval.
If the organization’s medical equipment quality management system complies with the requirements of ISO 13485, certification according to this standard means that the organization also complies with the requirements of ISO 9001.
Setting up a quality management system according to the requirements of ISO 13485 …