S
Sandeshgk7
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?
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?