We use 3rd party suppliers for things such as ECG cables, SPO2 probes, batteries etc and I have no sleepless nights over the worry of using them.

I think the MDA pitch is more aimed at "working" parts of the equipment as opposed to peripherals.

I ask myself the question, If everyone is using OEM parts, including peripherals, how come these 3rd party companies are in business?

If they are not supplying to anyone, where are they making their money?


Why worry, Be happy!