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.
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.