Earlier quoted context omitted.
>overly strict Disclaimer: my opinions, not my company. I worked as a project engineer for a major testing company (underwriters laboratories). This is a vast simplification, but in essence the difference between medical device testing verses say, household electronics, is that in practice household electronics get evaluated with a "safety checklist" of all the serious and common problems to that kind of device (plus…
I don't disagree. Testing should be as strict as is needed. I'm arguing/assuming that US testing standards for medical devices is overly strict. I think* there is the same "maximum" standard for all medical devices. But what's appropriate for a pacemaker is overkill for a CPAP machine. * but am happy to be corrected (Cunningham's Law)
There are multiple classifications for medical devices.
CPAPs are class 2 devices whereas a pacemaker is class 3. I don’t want to over simplify, so I will link you to the FDAs entry point into the Byzantine maze of classifications.
https://www.fda.gov/medical-devices/overview-device-regulati...