K
KAMay
I'm trying to get my head around 62304 and risk management
we have a class IIb device upon which a full risk analysis has been performed (adhering to BS EN 14971:2009) - do we need to do separate risk analysis for the software? Is there any guidance document on additional questions you should ask outside of those suggested by 14971? I have been assuming that one was enough but I don't want to leave myself short
Today I've got myself very confused with the standard which I thought I had in the bag.. do I need to specify the class of this software in addition to the device class - I've just realised our company has never been pulled up before for not having done so - is our device essentially two medical devices (eg class IIb and software class A)?
we have a class IIb device upon which a full risk analysis has been performed (adhering to BS EN 14971:2009) - do we need to do separate risk analysis for the software? Is there any guidance document on additional questions you should ask outside of those suggested by 14971? I have been assuming that one was enough but I don't want to leave myself short
Today I've got myself very confused with the standard which I thought I had in the bag.. do I need to specify the class of this software in addition to the device class - I've just realised our company has never been pulled up before for not having done so - is our device essentially two medical devices (eg class IIb and software class A)?