There are: ISO 13485 and 62304. And different levels of design and testing for different classes of medical device. For example, I worked on a new ventilator a

There are: ISO 13485 and 62304. And different levels of design and testing for different classes of medical device. For example, I worked on a new ventilator at the start of the pandemic (https://www.cambridgeconsultants.com/press-releases/building-life-saving-ventilator-lightning-speed https://www.cambridgeconsultants.com/press-releases/building...). As a medical device that was "in the loop" of keeping the patient alive, some of the strictest restrictions applied. There were 2 MCUs - one doing the control work, and another monitoring that first one, checking it agreed with the decisions and sounding an alarm if not. These two processors had to be different manufacturers, and had to use separate development teams (all to reduce the chance of a common mode failure). The regulators are just checking you do the process though: does it look like you have done your design rigorously, and tested thoroughly. There's no way to check that you've done your design well though.