Are internally found Medical Device Software "Bugs" Complaints?



Hi Folks,

I have a question regarding how companies have interpreted the FDA regs (and ISO) relating to Complaints. We are trying to determine whether any software bug that might be found internally should fall into the Complaints process as if it had been reported by a customer? For example, when testing as part of development of a new release we may sometimes uncover an obscure bug which exists in a previously distributed product, but which has never been found or reported by a customer.
Should this be classified as a Complaint? If not, under what process would you capture and review it?


I am not familiar with software devices. But I think the "Bugs" identified internally are not Complaints. They can be "nonconformities", therefore, I think you may want to handle the "Bugs" through Nonconforming Product Control and CAPA if an investigation is required.

Ronen E

Problem Solver
I agree with Nicole. Complaints are negative feedback from outside the organisation.

In my understanding a software bug is a situation where a software process doesn't perform as specified to (or as expected to, as an indirect result of a specification), thus it would be a NC. Your situation is not different in essence from one where a physical flaw is realised internally in a physical device already on the market. The exception would be where the discovery is not a clear deviation from a specification or a requirement, but more of a realisation of a way to do things better. In that case I would use the Design Control processes to initiate a review and decision regarding implementing an improvement (a design change).



Interesting question. I disagree with the previous posts.
Via the FDA 820.3
(b) Complaint means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.

It's probably not a huge deal, but technically it should be logged as a complaint if the product is on the market.
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