B
bmelissam
We repackage, relabel and distribute devices, we do not complete manufacturing of medical devices. We will have an MDSAP audit in 2017 and need to meet the explicit Risk Based approach of 13485:2016. Looking for some examples of how others are meeting this requirement.
Specifically the MDSAP audit Model states under process management objective eidence will show whether the organization has:
G) Performed risk management planning and ongoing review of the effectiveness of risk management activities to ensure that policies, procedures and practices are established for analyzing, evaluating and controlling risk
Specifically the MDSAP audit Model states under process management objective eidence will show whether the organization has:
G) Performed risk management planning and ongoing review of the effectiveness of risk management activities to ensure that policies, procedures and practices are established for analyzing, evaluating and controlling risk