Software that Print reports that may influence the use of a device via the operator of the device?

Hey there!

I bring this issue on to the table, I have this all month in my head and i cannot find a strong justification for this issue.

I have a software that collects data of steam sterilizers machines (# of cycle, temperature, pressure, etc.) and show them "nicer" in the PC with a nicer interface. The data is not altered, changed, nothing.

The software can create a report, via the interface (screen) and in a printed PDF.
The report contains the values of the pressure and temperature per second of the sterilizarion cycle.

Here comes the issue, when the operator watch this report, he/she could interpret the results and decide if the sterilizer cycle was correct or incorrect. in case of incorrect, he/she must "operates" again the sterilzer machine to re-sterilize again looking forward for a proper sterilization.


THEN, this report (Either displayed on the screen or printed PDF), can fall under the definition of software that drives or influence a device?

NOTE: and what if, the software's intended puporse is: "software that prevents HAI (hospital aquired infections) by monitoring the performance of the sterilization of sterilzer machines by measuring its physical parameters, reporting them to the operator"

Now with a prevention of diseases intended purpose, the software would fall out of the definition of software driving or influencig a device?

Thanks a lot!
I hope the problem is understandable

If this is FDA read the details of the CURES act. It discusses this exactly

I found the guideline. it is named "Clinical Decision Support Software"

Wonderful FDA guideline. it solves my issue, technically, my software would not fit under the FDA medical device definition.

But sadly, it is intended for Europe (MDR), and i think the mdr does not have this beautiful guideline considered anywhere.

However thanks a lot for the input! really useful guideline!