R
Revsar
Hi Everyone,
we have an off-the-shelf X-Ray equipment, used to measure molded components.
the software has a model built for each component, and when the component is measured - the equipment compares the measured values to the model, to determine whether the measured components meet specs.
the equipment is validated and calibrated, but I wanted to check if a software validation is required for this kind of equipment (for medical devices)
thanks
we have an off-the-shelf X-Ray equipment, used to measure molded components.
the software has a model built for each component, and when the component is measured - the equipment compares the measured values to the model, to determine whether the measured components meet specs.
the equipment is validated and calibrated, but I wanted to check if a software validation is required for this kind of equipment (for medical devices)
thanks