Test Method Validation or MSA for Batch Manufacturing

#1
Hello All,

I have question regarding Test method validation for Manufacturing of products in batch wise

We are medical device manufacturers(assembly only) ,Radiography devices in particular. we manufacture 10 devices per year and we use various measuring instruments like Vernier caliper, micrometer etc. number of times in different methods (to measure width,length distance etc) during the assembly of our devices.

My query is

1) Do we need to conduct Test method validation for all measuring methods?
2) If we need to conduct then how to decide the sample size, since sample available is only 1 for every assembly of a device?
 
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yodon

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#2
What's your confidence that the measurement method will produce results with the desired accuracy? What's the risk if the method doesn't produce the desired results? If patient harm is at stake, you'd certainly want to validate your methods to give yourself the highest level of confidence.
 
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