I worked in medical electronic manufacturing. Changing a single setting for ease of use to the operator was planned as a 2 year project. Literally change a 0 to 1 in one of the files…
A friend of mine writes code for the control systems in nuclear power plants. He told me, on average he writes 13 pages of documentation for each line of code.
Absolutely. I got well acquainted with the regulations. The sad part is it was so slow to update anything nothing got updated.
This system needs to be operational by next week.
It will be a month before its well made.
This needs to be operational by next week.
Ok, but then we can fix it right?
Not to mention any changes to anything got evaluated as either a notice update, a 90 day submission, or a full submission(6 months - 2 years depending on fda, bsi and severity of change). That’s in addition to the actual work. I could make a change in a afternoon and may see it in production next year.
I worked in medical electronic manufacturing. Changing a single setting for ease of use to the operator was planned as a 2 year project. Literally change a 0 to 1 in one of the files…
A friend of mine writes code for the control systems in nuclear power plants. He told me, on average he writes 13 pages of documentation for each line of code.
I’d imagine that one is because of medical more than anything else. There are all sorts of regulations around medical devices. That slows shit down.
Absolutely. I got well acquainted with the regulations. The sad part is it was so slow to update anything nothing got updated.
This system needs to be operational by next week. It will be a month before its well made. This needs to be operational by next week. Ok, but then we can fix it right?
Not to mention any changes to anything got evaluated as either a notice update, a 90 day submission, or a full submission(6 months - 2 years depending on fda, bsi and severity of change). That’s in addition to the actual work. I could make a change in a afternoon and may see it in production next year.