[QuercusMax]

Example: I work in medical devices, a regulated space. My job is 50% normal software engineering, and 50% dealing with BS regulations. It's part of the job. You can get annoyed at it, but it won't go away, and the job can be very fulfilling if you can get past the BS part.

[airbreather]

How many devices do you see or design have implicit state in the software controlling them?

(if it is not explcitly defined, and there is state based behaviour, it is by definition then implicit)

At the moment I'm trying to overcome the inertia on this issue in the general process/industry sector with child standards from IEC 61508 - 61511 and 62061.

I am guesssing you apply the medical standards IEC 60601?

Or at design of devices at component level then IEC 61508?

Interested to know how it fits in to the overall Functional Safety approach.

[QuercusMax]

I work on software as a medical device, so I have no idea about hardware safety controls. I have to deal with change control boards and approval matrices for every new build we push, though.