EN 82304-1:2017 | EN 62304:2006/A1:2015

[Vckytr]

Good afternoon

I put forward the following scenario

If we have a medical device that requires software for the configuration of the device, which is used on a PC, communicates only with this device for this function, and cannot be used for this purpose in any other medical device and is not sold separately.

Do you consider EN 82304-1:2017 or only EN 62304:2006/A1:2015 applicable?

Do you consider this software as a component or as an accessory of the medical device to be configured?

I am waiting for feedback about this.

Thank you in advance for participating in this discussion.

 

[yodon]

Do end users run the configuration software?

 

[Vckytr]

Do end users run the configuration software?

Hi, Yodon

Yes, they do

 

[yodon]

I would then consider it part of the system. I would follow IEC 62304, but would likely justify a lower safety class than the device software.

Don't forget cybersecurity.

 

[Vckytr]

Dear Yodon

Thank you very much for your feedback and contributions.

I will take them into account

 

[Ed Panek]

Depending on the reviewing party what @yodon said on Cybersecurity is key.

 

[Vckytr]

This is true. Thank you for your guidance