ISO 13485 is an international standard relevant to quality management systems for medical devices. The latest version was published in 2016 and reconfirmed in 2020.
This standard specifies the requirements for quality management systems for medical device manufacturers to provide safe products for use and in accordance with the regulatory requirements of international bodies. It includes requirements for documentation, personnel qualification, risk management, change control and validation, among others, to ensure that medical devices are safe and effective, and that quality and compliance are maintained according to the applicable regulatory requirements.
The standard is suitable for medical equipment organizations regardless of their size or specific type of medical device or equipment.
To the article ISO 13485 in the medical industry