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Software Updates in the Field and ISO scope

KatieQA

Starting to get Involved
#1
Our registrar auditor casually mentioned that performing software updates to medical devices in the field is considered installation. We currently have scoped out installation from our ISO 13485:2016/MDSAP certificate, but plan to launch a medical device soon that will have software and want to plan for inevitable updates.

Can anyone confirm or reject the auditor's assertion? Do we need to expand our scope?

Thanks!
 
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yodon

Staff member
Super Moderator
#2
It's troubling to me when auditors try to shoehorn in concepts that, while arguably, may be considered part of software, the paradigm is different. (end of rant). I don't particularly see software installation falling under 7.5.3 but you'll need to decide if that's a fight you want to take on.

Unless you physically install the software, you have little control over the process. You can (and should) do some things to ensure the system is running on a supported system, is not corrupted, etc. But unless you do the installation, good luck getting a user to provide a record that verifies installation.
 

akp060

Involved In Discussions
#3
but plan to launch a medical device soon that will have software
Is the software integrated into the medical device or is it planned to be "installed" separately? Also, have you outsourced the installation of the "medical device"?
 
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