Hi everybody,
I hope you can guide my on something.
I’m writing pFMEA for packaging process for packaging medical device and i’m analysing the process to find all the risks that can produce harm to user/patient.
The pFMEA should answer the requirements of MDR and ISO 14971 and i’m not sure how to do benefit-risk analysis for each individual risk (do i need to do that for every risk?) and i should i do overall benefit risk analysis?
Examples will help.
I hope you can guide my on something.
I’m writing pFMEA for packaging process for packaging medical device and i’m analysing the process to find all the risks that can produce harm to user/patient.
The pFMEA should answer the requirements of MDR and ISO 14971 and i’m not sure how to do benefit-risk analysis for each individual risk (do i need to do that for every risk?) and i should i do overall benefit risk analysis?
Examples will help.