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Medical Device Shelf life studies


Starting to get Involved
Hi all
At my firm we have a discussion ongoing regarding items used for the first lot in shelf life studies. How do you see it, should items come from a validated production line or are prototypes ok because shelf life studies is part of design verification testing?

looking forward to hear your views on this matter..
I agree with indubioush, but what this "should" mean is that you maintain all documentation needed to show that the prototypes do, in fact, represent the final finished device in terms of design and processing. (I have found that once some people here "prototypes are fine," they fall deaf to whatever comes after.)

I will add that although "prototypes are fine" for use in testing, often development teams come to regret it, because what this also "should" mean is that, from that point forward, you must be able to justify that the test results obtained with the prototype are still applicable to the market product after any changes to design or process, which must then be assessed from that perspective. It often turns out that the design and process were not so "near final" as everyone thought, and this can create a lot of headaches, to say nothing of the fact of a waste of money, should it turn out that the changes are such that you cannot justify that the original test results are still applicable, and therefore have to repeat the testing.
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