ISO 13485 is a system of quality management standards covering the design, development, manufacture and sale of medical devices. These system requirements apply internationally, such as Europe, Canada, Australia.  ISO 13485 is based on ISO 9001 processes and management system standards developed for medical device manufacturers.

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The main objective of this standard

• Regulating the medical device industry in accordance with international standards

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This standard contains specific requirements for manufacturing, installing and servicing, including:

• Implementation of a multi-improved quality management system

• Guidelines for product development and distribution with a risk management approach

• process confirmation

• Compliance with Terms and Regulations

• Efficient product tracking and recall system