Hi All
Per ISO14971:2019; the manufacturer must document the method and criteria for overall residual risk evaluation in the Risk management plan.
I am wondering if you have any idea what could be some possible method and criteria for overall residual risk evaluation.
I am slightly confused by difference between method and criteria.
if i say my criteria is :" " The overall residual risk level is acceptable if all individual risks are determined to be acceptable i.e. after all individual risks have been mitigated to acceptable levels or determined to be acceptable through the BRA analysis."
Then is my method just : "checking all residual risks in my risk files and confirming all risks are acceptable"?
Thank you
Mithilesh P.
Per ISO14971:2019; the manufacturer must document the method and criteria for overall residual risk evaluation in the Risk management plan.
I am wondering if you have any idea what could be some possible method and criteria for overall residual risk evaluation.
I am slightly confused by difference between method and criteria.
if i say my criteria is :" " The overall residual risk level is acceptable if all individual risks are determined to be acceptable i.e. after all individual risks have been mitigated to acceptable levels or determined to be acceptable through the BRA analysis."
Then is my method just : "checking all residual risks in my risk files and confirming all risks are acceptable"?
Thank you
Mithilesh P.