ISO 13485 is a quality management system that covers the design, development, manufacture, and sale of medical devices. The requirements of this system are applied internationally, such as Europe, Canada, Australia.
ISO 13485 is based on the process of ISO 9001: 2016 and the developed management system standard for medical device manufacturers.
The main purpose of this standard is to regulate the medical device industry in accordance with international standards.
This standard contains specific requirements for manufacturing, installation and service, which include:
– The use of several quality management systems has been improved.
– Guidelines for developing and distributing products with risk management guidelines.
– process confirmation
– Compliance and Regulations
– Powerful tracking and recall system.