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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?
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?