As some might be tempted to say, ISO 13485 is the underpinning, and specific standard for the QMS for medical devices and in-vitro diagnostics, and thus, this is the way to go, there are many more possible roads to take.
Depending on the type of economic operator, different aspects of processes need to be implemented. As ISO 13485 is specific to medical devices, it is based on other standards, such as ISO 9001, and has basic commonalities with other standards or QMS, such as GMP.