Off the shelf tablet - how to handle it?

#1
Hello,

I'm currently working for a company which is developping an implanted medical device.
This medical device is configured with a dedicated software which is supposed to run on an off-the-shelf medical tablet.
How far shall we integrate this off-the-shelf medical tablet in our DHF/DMR?
How far shall we integrate this off-the-shelf medical tablet in our risk analysis?
How far shall we integrate this off-the-shelf medical tablet in our standard tests (i.e. IEC 60601-1, IEC 60601-1-2,...)?

How shall we indicate in the labelling that the software shall run on this specitic tablet?

Is there a FDA guidance explaining this topic?

Thanks in advance

Best regards

Clément
 
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William55401

Quite Involved in Discussions
#2
The tablet (your implantable device programmer) is a purchased item (21 CFR 820.50 Purchasing Controls!) that is being used as part of a medical device. Certainly, it is in scope of your DMR, DHF including Risk Mgmt File. As the manufacturer, your org is ultimately responsible for safety (including electrical) for this consumer electronic.

Your IEC 60601 question is valid. I am in the exact same space right now with a class I device that uses a very popular phone for gathering, analyzing, and transmitting data. For our low risk device and lack of direct patient contact (no leads), we are working through a rationale (with no testing) for electrical safety. Intent is to leverage (if possible) EU Declarations of conformity that are related to IEC 60601. That's our thinking on a generally recognized as safe class I product. We still think some EMI testing may be needed.

Ultimately, your org knows the product and the use scenarios for your tablet and implantable combo. Hope this helps. Have fun; enjoy the ride.

Edit: Not aware of FDA guidance on this topic.

Edit 2: I am happy to connect with EE consultants who have experience in this space (consumer electronics used as part of a medical device solution) and are willing to go on record with an assessment. Please private message me!!
 
Last edited:
#3
Thanks for this quick answer.
My question about IEC 60601-1 and IEC 60601-1-2 is not detailed enough.
The tablet is a medical one, it is certified IEC 60601-1 and IEC 60601-1-2.
Can rely on the IEC 60601-1 and IEC 60601-1-2 test reports provided by the manufacturer or shall we perform another tests with the tablet and the software?
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#4
As mentioned purchasing controls. Risk evaluation on the item and how it could fail and implications of failure, cybersecurity plan. Can you lock it down with admin control so no updates or changes or deletions can occur? A hardened file system may be needed. Disabling BIOS or i/O ports in BIOS with password protected.

Also EMC 60601 testing for the indicated environment of use.

How integrated is usually based on risk.
 
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