Medical Device Component Change - Testing, Sampling Criteria

[jpxusked]

Hi,
Our company manufactures IVD medical devices and biopharma devices. We are in process of switching a component (display) due to supply chain issues. I was hoping that I could get some feedback here as to what the proper number of samples we should test to validate this change. We have already verified fit/form/function on all our important specifications including EMC and environmental conditions (using 8 systems) and all of the specs of the new component meet or beat the current ones. The question here is what the thoughts are on how many items we need to test to have a 95% confidence level that the replacement will be good.
Thanks

 

[Tidge]

The question here is what the thoughts are on how many items we need to test to have a 95% confidence level that the replacement will be good.
Thanks

Are you concerned with attribute data or variable data?

 

[jpxusked]

It is really only attribute data - works or doesn't work - or more specifically meets our design specs / criteria / or not and functions are required.
Thanks

 

[Tidge]

What sort of Tolerance and Confidence levels are you hoping for?