ISO 13485
ISO 13485 is an international standard for medical device design and development which specifies requirements for a comprehensive quality management system in order to ensure that products conform to customer and regulatory requirements. In other words, ISO 13485 is a quality management system standard that was specifically created for the medical device industry. It helps companies ensure that their products are safe and compliant with regulations.

https://iasiso-middleeast.com/blog/iso-13485/