Hi all, a quick question.
Latest edition of iso 14971 refers the risk management throughout the whole lifecycle.. may i confirm if the corresponding risk is referring solely to the risk created by the device on its actual user/customer?
How about the risk of manufacturing operator injury (while manufacturing this device) which is typically covered by pfmea?
Thanks in advance.
Latest edition of iso 14971 refers the risk management throughout the whole lifecycle.. may i confirm if the corresponding risk is referring solely to the risk created by the device on its actual user/customer?
How about the risk of manufacturing operator injury (while manufacturing this device) which is typically covered by pfmea?
Thanks in advance.