Device History Record - Post Shipment - Class II Medical Device w/ Embedded Software

We market a Class II medical device with embedded operating software. We record the software version on the DHR prior to shipping. No surprisingly, we constantly provide our customers upgrades to the original software. Question: do these version upgrades need to be reflected in the original DHR? Or - is the DHR per se "sealed" at the point of shipment? Thanks.

Re: Device History Record - Post Shipment - Class II Medical Device w/ embedded softw

I think the DHR should be updated if you provide software updates.

Re: Device History Record - Post Shipment - Class II Medical Device w/ embedded softw

Our thoughts exactly, though the updates will live in a completely separate database. I'm now thinking that we may also ned a procedure that describes where the various components of the DHR live...! Thanks again!

Re: Device History Record - Post Shipment - Class II Medical Device w/ embedded softw

This was a good post. Made me go back and read the reg!

I didn't see anything in the reg that indicated you need to have the updated information in the DHR. In fact, the reg reads just like you asked - a snapshot at the time of release. There are plenty of references (and it makes sense from a business perspective) for keeping track of the updated information and the DHR is a _logical_ place. That's what we have done and have suggested our clients do.

Re: Device History Record - Post Shipment - Class II Medical Device w/ embedded softw

Our sentiments exactly. And although these post-shipment updates don't live in the same physical DHR, they do reside in a database that is referenced in the DHR procedure. Thanks very much for your confirmation!!

Re: Device History Record - Post Shipment - Class II Medical Device w/ embedded softw

When you make an upgrade to software (i.e. software as part of the product), you are changing your design. Thus, the software has to undergo a design change, no matter what changed. Therefore, a new DMR and DHR need to be created regarding this approved and validated software change.

Re: Device History Record - Post Shipment - Class II Medical Device w/ embedded softw

Watchwait said:

We market a Class II medical device with embedded operating software. We record the software version on the DHR prior to shipping. No surprisingly, we constantly provide our customers upgrades to the original software. Question: do these version upgrades need to be reflected in the original DHR? Or - is the DHR per se "sealed" at the point of shipment? Thanks.

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I think the Design History File should be updated accordingly. If a next generation product is launched everything will be expected to be traceable and evidence that development was in control.