Finally sorta done
We finally managed to "sorta" finish enough of the 510(k) to send it to the regulatory consultant. If we hurry it will only be submitted 2 months behind the original schedule, I have a big horn tooting post planned for then. By sorta finished I mean I need to slip a few more details into the software section before its final and the poor VP is double checking my traceability analysis line by line and he'll probably have a few changes. That is the reward he gets for also being the management quality rep.
You can drive yourself nuts attempting to second guess what the FDA wants as far as a software validation, it is almost purely a judgment call. I could easily write another few months software testing into there, would it be useful testing? 99% of it probably not, but it takes that 99% to find the 1% where there may be an issue. Is it worth it to spend half a day rigging up a test to show that if the hard drive is full the software can deal with it? At least 20 gb of free space, and the files are less than 100 kb, if someone fills that up we sold them tens of millions of dollars of disposables- if only! Much of this has to come down to trust on the FDA's part, because outside of having 2 guys test the machine for 6 months (in my experience they don't ask to even see the machine), it is difficult for them to judge the quality.
It was getting a little tense at work for a while, hopefully with the 510(k) out of our hands we can get back to normal. There is still a lot of work to be done, a couple items in the 510(k) we told the FDA we'd finish before clinical use, but the bulk of the work has moved from product development work to mostly manufacturing fine tuning. Everything needs fixtures and some bugs in the process need worked out to get the product consistency we need. If that wasn't enough we're also moving the company, which is scheduled to be a one month delay, but I foresee a three month delay in progress.
PS My wife has assured me that the new header matches the rest of the blog, green and brown matches, who knew?
3 comments:
hmm..I think the earlier header was better..this luks kinda mismatch..
Interesting. We are just starting to audit one of our suppliers software that they will be submiting for 510K approval. However, their docs appear to be non-existent or a mess.
We asked the software consultants to write the first attempt at the design spec, requirements, V&V, etc and it pretty much needed a complete rewrite and still isn't where I'd like it. Hopefully I'll better be able to estimate the time it takes to finish these documents in the future, the ~1 month we had scheduled was off by at least 3!
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