HI
I am conducting PMS for class IIB DEVICE per EUMDR requirement. Last year I had a change in occurrence for a defect in my risk file based on customer complaint data. This shifted the occurrence to a higher level which resulted in a medium level or risk resulting in a benefit risk assessment.
based on the PMS data and customer complaint data..our occurrence levels have actually gone down without us taking any corrective actions. The occurrence level calculation is based on a complaints per million rate. If I use the lower occurrence to do my risk evaluation, I get a low risk and my risk is now acceptable.
My question is: can I use this occurrence data to now reduce my risk to an acceptable level which was unacceptable an year ago?
thanks
I am conducting PMS for class IIB DEVICE per EUMDR requirement. Last year I had a change in occurrence for a defect in my risk file based on customer complaint data. This shifted the occurrence to a higher level which resulted in a medium level or risk resulting in a benefit risk assessment.
based on the PMS data and customer complaint data..our occurrence levels have actually gone down without us taking any corrective actions. The occurrence level calculation is based on a complaints per million rate. If I use the lower occurrence to do my risk evaluation, I get a low risk and my risk is now acceptable.
My question is: can I use this occurrence data to now reduce my risk to an acceptable level which was unacceptable an year ago?
thanks