Hello people of the forum 
Do you consider risks triggered (only) by potential bugs in your medical sw risk management charters?
I am not talking about known issues, bugs already found and decided not to fix, but potential bugs that apparently are not affecting the product (but of course could potentially be there... you never know!).
For instance, if I have a sw aiming to automate the design of an implant, should I consider the possibility that a bug escaped to our V&V process?
As a rule of thumb, I would say yes, it should be considered... but on a practical level, this would mean to list in the RMC an endless list of potential, very remote probability of occurrence bugs...
Looking forward to hear your opinions.
Have a nice day (despite the hard times)!
Do you consider risks triggered (only) by potential bugs in your medical sw risk management charters?
I am not talking about known issues, bugs already found and decided not to fix, but potential bugs that apparently are not affecting the product (but of course could potentially be there... you never know!).
For instance, if I have a sw aiming to automate the design of an implant, should I consider the possibility that a bug escaped to our V&V process?
As a rule of thumb, I would say yes, it should be considered... but on a practical level, this would mean to list in the RMC an endless list of potential, very remote probability of occurrence bugs...
Looking forward to hear your opinions.
Have a nice day (despite the hard times)!