Validation of OTS (Off The Shelf) Software in Medical Devices

tebusse

Involved In Discussions
#1
Greetings,

I have a question or two regarding the validation process of OTS software that is used by our medical device, which is also software.

For example, if our device required Adobe Flash to play loops of ultrasound images (viewer), would we have to validate the player by itself and then validate the viewer?

Or, is just the overall validation of the entire device enough to satisfy the requirements of validating OTS software?

Regards, Tonia
 
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sagai

Quite Involved in Discussions
#2
Re: Validation of OTS software in medical device

It is a kind situation when you are about to open Pandora's jar with this question and at the end I am not sure if you would curse me or appreciate for the reply you get. :D

For US legislation, there is a nice guidance from FDA I would suggest to look into.
http://www.fda.gov/downloads/Medica...onandGuidance/GuidanceDocuments/ucm073779.pdf
It is clearly saying what they may expect, but as long as it is a guidance, any manufacturer can be a superhero to challenge an alternative way due to the fact that guidances are not strictly mandated to follow.

For EU, you will not find such guidance, all we have is a volunteer harmonized standard called IEC62304, that describes the related activities. All you have to bear in mind that whatever you do or not do should be conform with the Essential Principles. Moreover it more or less up to the notified body discretion, what level of control they may or may not like to see.

So, here is my answer, knowing the above, you can script your way. ;)

Cheers!
 

Marcelo

Inactive Registered Visitor
#3
Re: Validation of OTS software in medical device

In the case of your particular example, does the loops of ultrasound images affect safety?

In a more general answer, if you use an OTS component in your software, it's generally considered unsafe because it was not validated for your use. You don't need to validate it alone as long as you do not use it for a safety-related activity.
 

tebusse

Involved In Discussions
#4
Re: Validation of OTS software in medical device

Let's say for example the image loop player does affect safety.

Then, the OTS software running the image loop would require separate validation for our intended purpose? Isn't validating the image loop player system considered validation of the player for our intended purpose?

I'm a bit confused...
 

Marcelo

Inactive Registered Visitor
#5
Re: Validation of OTS software in medical device

It would be if you created them all together, but as it's OTS, you would be better validating it alone first (to make sure that you CAN use it as intended), and then validating the system as a whole.
 

tebusse

Involved In Discussions
#6
Re: Validation of OTS software in medical device

Okay.

Different scenario...

What about OTS software that is used to help build the device, such as building template reports or working to speed up development? I'm not sure how these items would affect patient safety.

However, if they're listed as tools used in the development process, do we have to validate them anyway?
 

Marcelo

Inactive Registered Visitor
#7
Validation of OTS software in medical device

Depending on how they affect, yes, but due to quality system requirements, not "directly" device design requirements.
 

sagai

Quite Involved in Discussions
#9
Re: Validation of OTS software in medical device

There is a subtlety on this subject.

OTS encapsulated into the device needs to be validated to ensure the safety of the device, whereas OTS used to create/etc. the device needs to be validated to comply with 21CFR820.70(i), and OTS relates to verification should be because of 21CFR820.72(a).

... and because of general interest to have something that we are sure about.

actually, I think some part of the validation should have been occurred as part of supplier evaluation ...

and you need to think about how to maintain the validated state of these OTS applications, I mean as regard to new versions of these OTSs including service packs and hot fixes.

but that's more or less US legislation driven.

Cheers!

On more thing.
I would encourage you to work out your own way rather than voluntarily bind yourself to any available standard kind of thing like GAMP, IEC62304, AAMI TIR36, etc. because first of all you already have professionals for software development, and whatever policy you will have at the end the people in your organization should accommodate it, and not for last in terms of external audits you will be utterly vulnerable if you use some kind of canned solution including the IQ/OQ/PQ thing you have mentioned. That is not for software. The origin of that stuff is coming from the pharmaceutical industry to validate production lines!!!. The only thing I would not ignore is the above mentioned FDA guidance for OTS built into the product. If your target market includes US, it is better do the way stipulated by FDA. For non product related OTSs, I would simple use common sense and the knowledge already exist in the organization.
 
Last edited:

Statistical Steven

Statistician
Staff member
Super Moderator
#10
I have a more generic question...how can you validate OTS when you do not have the source code? You can VERIFY that the OTS performs in your device, but unless you have source code, hard to write test scripts.
 
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