Retrofitting Medical Devices - Who is the Manufacturer after the Retrofit?

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MIREGMGR

#12
There's another worthwhile question that hasn't been asked, so I'll both ask and answer:

What does "fully refurbish" mean, and how is that distinct from some lesser degree of refurbishment?

That particular unfortunate choice of wording means, I think, that if the refurbishment includes one or more aspects of the equipment that could reasonably be expected to significantly affect or determine its clinical safety and/or effectiveness, that's "full refurbishment".

If on the other hand the refurbishment was in regard to secondary issues like cosmetic detailing, functional but not-very-clinically-significant replacement of such items as external bumpers or casters, or other non-clinically-significant cleaning or repainting, that would not be "full refurbishment".

My understanding is that maintenance-technician performance verification, alignment, etc. is not refurbishment if it is of the same nature as normally expected periodic maintenance and verification, even if it's conducted by a company that otherwise sometimes performs refurbishment, but major functionality corrections by the same maintenance technician may be refurbishment even if they don't involve significant parts replacement.
 
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