There is a very fine line between refurbishment and remanufacture and that line is becoming increasingly blurred. The Australian TGA no longer draw any distinction between the two when they consider the refurbishment to be "complete". The FDA are becoming increasing vigilant of companies that use the term "refurbushment" to exclude themselves from the 21CFR's. In their opinion as soon as the latest version of the operating software is uploaded, or tube or detector is up-rated you are straying into
remanufacture and are thus under the auspices of ISO13485 and 21CFR820
et al.

In my opinion it would make sense to extend the ISO13485 QMS coverage to include your refurbished products - this may also serve to offer you a clear competitive advantage against many of your competitors who are going to find it increasingly hard to call themselves refurbishers, at least in the eyes of the FDA.
I would be interested to hear what anyone else thinks on this topic.
Jimmy