M
hello to all
I'm new here. I'm glad that I can share my knowledge with you.
Here is a great forum.
now I'm working on the CE marking a standalone software.
We develop a software for ecg analysis. Class B according to IEC 62304
I want to know if IEC 80002-1 can be used for risk management our software or it is for medical products with software (not stand alone).
does anyone have an example of risk management for software?
Thank you very much
best regards
I'm new here. I'm glad that I can share my knowledge with you.
Here is a great forum.
now I'm working on the CE marking a standalone software.
We develop a software for ecg analysis. Class B according to IEC 62304
I want to know if IEC 80002-1 can be used for risk management our software or it is for medical products with software (not stand alone).
does anyone have an example of risk management for software?
Thank you very much
best regards