No validation for a contract specification and software developer?

I

icare2much

#1
Hi all, I've moved on from my old company to a new one where I'm setting up the quality system. We do specification work and some software development intended for ultimate inclusion by our customer in their medical device, as a component of it. Our software is not standalone, we do not manufacture anything, nor do we arrange for manufacture.

The question is about validation - I am getting heavy pushback from folks here who (rightly so, to a degree) believe that validation is the duty of our customer since we only do a portion of the final device. However, I look at it from a different view - we should validate to our customer requirements - independent of what our customer does with our design. I think there are two types of validation in the end - validation to our customer requirements, and the customer's validation to the intended use of the medical device.

I am trying to put together an ISO 13485 compliant system and will seek certification at some point, but its too early for that now.

I think our quality system should stand on its own, and I suspect a registrar would raise their eyebrows at anything in our Quality Manual that says "The customer performs validation for our stuff".

What do ya all think?
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
I would think your only validation requirements would be for the part(s) or assembly you actually manufacture and/or assemble.
 
I

icare2much

#3
We don't assemble or manufacture - I was thinking in terms of design validation...
 
D

danpa

#4
I think you are on the right track.
Your company needs to validate to your customers requirements. Your customer is then responsible for validating to their customers requirements.
That said, I would suspect that you are already performing (or planning to) validation to your customer's requirements/needs.
Each time your development team answers the question "are we building what they asked for and need" they are performing validation. Additionally, as a subcontractor, your customer should be conducting reviews of your design and implementation of the software - part of what they are doing is validating that your companies work will perform as needed in their device. Your customer also likely does some acceptance testing which again is validation of what your company produces.
All of this can be part of your validation plan.
 
I

icare2much

#5
I thought I had it and it slipped away...

We just had a review meeting for the Quality Manual and I wasn't able to adequately defend keeping 7.3.6 Design Validation in it. The opposing argument is based on FDA's definiton of validation -

establishing by objective evidence that device specifications conform with user needs and intended use(s).
Their argument is that we can't possibly test the intended use because intended use is for the finished medical device - and we only have a component.

Ugh. My instinct rebels against this but I can't come up with a compelling argument. Can anyone help?
 

yodon

Staff member
Super Moderator
#6
Certainly you can't validate the software as defined by FDA for a device since it's only part of the device.

What you can do to make sure your user's needs are met is to verify thoroughly, especially at the interface level. You can also have a well defined SDLC, including proper CM (including configuration status accounting).
 
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