FDA Requirements for Implantable Medical Device Software Validation

E

eileenr

#1
Good Afternoon Everyone,
I have a query and I am hoping someone can guide me. A company is making a small scale manufacturing unit for us to produce an implantable medical device. The machine has a piece of software that was originally bought off the shelf, but a piece of code has been added to make the software do what we need it to do- hence no longer validated as per the software manufacturer. I have been reading the FDA guidelines on software validation, I do not want to over complicate this but has anyone done this before, taken an existing software package, added some code and then validated it. Any help would be appreciated.
Regards
E:)
 
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yodon

Leader
Super Moderator
#3
The situation you describe is not uncommon and your assessment (no longer in a validated state) is correct. Thus, you need to take appropriate actions to bring the system back into a validated state.

You may be able to get some lift off of the original validation. If you can demonstrate that the changes are isolated, you may be able to limit the scope of the re-validation. Document your decisions as part of the validation plan.

There is, of course, more that has to go on in addition to (just) testing but that's probably too broad to cover in this venue.
 
D

dblnkl

#4
Good Afternoon Everyone,
I have a query and I am hoping someone can guide me. A company is making a small scale manufacturing unit for us to produce an implantable medical device. The machine has a piece of software that was originally bought off the shelf, but a piece of code has been added to make the software do what we need it to do- hence no longer validated as per the software manufacturer. I have been reading the FDA guidelines on software validation, I do not want to over complicate this but has anyone done this before, taken an existing software package, added some code and then validated it. Any help would be appreciated.
Regards
E:)
1. You do not say what class your implantable device is.
2. Suggest a risk analysis. That should add some perspective to the possible effects of your changes.
3. There is a basic rule of software - any change has unintended consequences. I.e., how can you insure the validity of your modified software without a full validation?
 
E

eileenr

#5
Thank you Yodon, I appreciate your help. I am reading all the FDA guidelines so hopefully I will be able to validate this software properly.
E
 
E

eileenr

#6
Good Morning dbINKL
I will do a risk analysis in order to determine any harm that can occur if this software does not do as its intended to do. I will get there, oh its a class IIA medical device.
However, its the machine that is manufacturing the device the software is not in the device itself.
Thanks for your feedback,
E
 
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