L
Lola Parra
Hello:
I have a doubt about software requirements specifications about my device software. My software is a class A and it?s embedded in a medical device. I?m actually using the IEEE Std 830-1998 to create the SRS document for the IEC 62304.
We have main software where all the software requirements specifications are included and verified. This system consist in user interface only where the user can access to all the operations (records, measure and visual testing), but my boss is thinking about if we can supplied an additional application only to show (never modify) the actual data saved into database.
It means, when you run the main software, the user can use all the functions of our system and visualizes the save data but not at the same time, for example, the user wants to measure a patient and visualize all this patient data but at the actual software it is impossible.
So, if we supplied an independent application only for showing patient?s data, must I include a reference of this application of any document for the IEC 62304? How? Where?
Thank you so much.
I have a doubt about software requirements specifications about my device software. My software is a class A and it?s embedded in a medical device. I?m actually using the IEEE Std 830-1998 to create the SRS document for the IEC 62304.
We have main software where all the software requirements specifications are included and verified. This system consist in user interface only where the user can access to all the operations (records, measure and visual testing), but my boss is thinking about if we can supplied an additional application only to show (never modify) the actual data saved into database.
It means, when you run the main software, the user can use all the functions of our system and visualizes the save data but not at the same time, for example, the user wants to measure a patient and visualize all this patient data but at the actual software it is impossible.
So, if we supplied an independent application only for showing patient?s data, must I include a reference of this application of any document for the IEC 62304? How? Where?
Thank you so much.