Hi,
I am just thinking that for chemistry analyzers (IVD instruments) which do not have a direct impact to the patient safety, how do companies report their removals and corrections.
If there is any replacement of power boards or repair at the customer site or at the manufacturing site, without reducing any risk to health of the user, then are these considered to be reportable repairs (corrections or removals)?
For such IVD instruments, are all repairs reportable under CAR (Correction and Removal regulations)? I don't think so.
How does Companies/Industry practice?
Please share your thoughts!
Regards,
sreenu
I am just thinking that for chemistry analyzers (IVD instruments) which do not have a direct impact to the patient safety, how do companies report their removals and corrections.
If there is any replacement of power boards or repair at the customer site or at the manufacturing site, without reducing any risk to health of the user, then are these considered to be reportable repairs (corrections or removals)?
For such IVD instruments, are all repairs reportable under CAR (Correction and Removal regulations)? I don't think so.
How does Companies/Industry practice?
Please share your thoughts!
Regards,
sreenu