ISO 13485 is a quality management system standard that is specific to the medical device industry. It helps manufacturers create products that are safe and effective for patients. To receive ISO 13485 certification (https://ias-certification.com/iso-13485-certification-in-usa/), a company must demonstrate that it has a comprehensive quality management system in place. This system includes processes for the design, development, production, installation, and servicing of medical devices.