I was wondering. By "devices" do you mean those devices that are some how hooked up to a patient, or somehow regulating something in or going to a patient, e.g., heart rate, flow of fluid, etc. ? That is my reading of the FDA document.

If that is the case, then wouldn't "devices" (e.g., a PC) that does not "touch" the patient, but only keeps track of records, schedules, facts, etc., not come under the FDA rubric? That might imply that software, such as FreePM, wouldn't be affected by the above-identified FDA rules.