I need to validate an optical inspection machine/system that is used to measure features of screws. These are screws that are used in conjunction with a class 2 medical device.
System is made by Oasis Inspection Systems. It is basically a shadowgraph with easy semi automaed edge detection and measurement capability.
I have heard that some medical device makers in U.S. use MSA (measurement system analysis) based on an ASTM E2782 std.
Others, specially makers who sell internationally, do a full on validation.
I would appreciate it if someone can provide info on which ISO stds I should use to validate this machine.
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Robert Nami
Carlsbad CA
United States
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