How document an additional software of my main device software??


Lola Parra

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.


Quite Involved in Discussions
Hi Lola,

It is a little difficult to fully understand what you are describing, but...

First decide if the additional is still a medical device, if not then you do not need to worry about 62304, if it is then the next question is,

is the risk profile different from that of the original device, if it is the same then the documentation will need to be similar to the original device.


Lola Parra

Hello Keith:

Sorry If I have not explain very well. For own medical device we include a software that control all the machine operations.

The additional software will be only to show the actual data from database. Actually at main software the user can access to this data too.

I explain again, for example, at the first window the user can consult all patient selected saved data, and next go to make more measurements at other window. But if the user still at measurement window but he wants to consult again actual data he must go to the previous screen.

The additional application will be used at the same time with the main software so allows to user consult data at the same time when is measuring.


Involved In Discussions
Even if you separate the software two parts: one for (just) visualization and another to control your device.
I think as Kreid said that only risk analysis will say that kind of software is and what is its class.
Assume that the values displayed are used to make a decision affecting the patient or operator health. No matter that your software be used "only for Display", it becomes medical software of a certain class.