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my company is in a bit of a quandary at the moment:
we are a long standing medical device manufacturer, and run somewhat old school. we are a small family owned business that has rather close ties to our customers. we are applying for iso 13485 certification, MDD and CE. here is the debate... since we have been doing business (approx 100 years) we have refurbished our older products with a lifetime guarantee, in order to please our customers. it seems as though the MDD and ISO regulations are against our company continuing to "update" or refurbish our products that are quite a few years old (to say the least; approx 10-30-50 yrs +). can someone please give me some advice as to what regulations say and where they would say it? i am currently trying to show the sr. managers what the ISO and MDD regs say regarding this issue, but they consistently "find that info hard to believe!". is is poss to refurbish the instrument under a "antique" or "for demonstration only" tag?
much appreciated.
we are a long standing medical device manufacturer, and run somewhat old school. we are a small family owned business that has rather close ties to our customers. we are applying for iso 13485 certification, MDD and CE. here is the debate... since we have been doing business (approx 100 years) we have refurbished our older products with a lifetime guarantee, in order to please our customers. it seems as though the MDD and ISO regulations are against our company continuing to "update" or refurbish our products that are quite a few years old (to say the least; approx 10-30-50 yrs +). can someone please give me some advice as to what regulations say and where they would say it? i am currently trying to show the sr. managers what the ISO and MDD regs say regarding this issue, but they consistently "find that info hard to believe!". is is poss to refurbish the instrument under a "antique" or "for demonstration only" tag?
much appreciated.

