Analytical Test Instruments Used in V&V

M

MDDRegAffairs

Hello all,

We are interested in running a test to demonstrate repeated use of our product does not increase temperature beyond some threshold. We purchased a FLIR camera to take the thermal measurements. What if any responsibility do we have to demonstrate the thermal camera is working correctly? Do we need to validate the camera and associated data acquisition software? The manufacturer of the camera had no comments.

Any guidance would be greatly appreciated,

kind regards,

MDD
 
Ronen E

Ronen E

Problem Solver
Moderator
MDDRegAffairs said:
Hello all,

We are interested in running a test to demonstrate repeated use of our product does not increase temperature beyond some threshold. We purchased a FLIR camera to take the thermal measurements. What if any responsibility do we have to demonstrate the thermal camera is working correctly? Do we need to validate the camera and associated data acquisition software? The manufacturer of the camera had no comments.

Any guidance would be greatly appreciated,

kind regards,

MDD
Click to expand...

Hi,

My :2cents: :

1. The set-up is a measuring device and needs R&R analysis including calibration.

2. The software part needs software validation since it's not an integral part of the camera. Perhaps the software supplier can help with this part.

Cheers,
Ronen.
 
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