We receive a new CNC machine from a different plant and since we are certified in iso13485 process validation should be performed,
the other plant is not in the medical device branch so a validation was not performed.
The IQ has been completed but specifically this machine only have a speed parameter which does not have a reference unit of measure it is presented as a percentage, also the parameter was locked by the supplier.
am i able to jump from the IQ to the PQ? (avoiding the OQ with a justification)
Our products are Foam Positioners, Medical dev 1
Any guidance regarding this issue will be very helpful
Thanks
the other plant is not in the medical device branch so a validation was not performed.
The IQ has been completed but specifically this machine only have a speed parameter which does not have a reference unit of measure it is presented as a percentage, also the parameter was locked by the supplier.
am i able to jump from the IQ to the PQ? (avoiding the OQ with a justification)
Our products are Foam Positioners, Medical dev 1
Any guidance regarding this issue will be very helpful
Thanks