Jan 20, 2008

End of the 510(k) line

I know how Creo Quality (sorry to post off of Creo so much, but I can't find many other device blogs) feels, the closer you get to your deadline, the more you think, we should (or think we should) have discovered these problems months ago. Our device incorporates an air detector to ensure air doesn't enter the patient's bloodstream, it is a fairly common accessory for any device with an extracorporeal circuit. We just discovered recently that the software was set up to check the air detector every half second, at our flow rates more than 50 ml of air could have gone by in half a second. Thats is why we do the validations. It is a relatively simple job to change the scan rate and then retest that it works correctly this time, probably takes about a week overall, but at this stage every delay is painful and they start to add up.

I've been fairly lucky this week though and haven't caught much flak, management has been occupied with self inflicted problems that I'm not part of. The 510(k) checklist hasn't had many tasks crossed out the last few weeks though, most of it is due to contractors or consultants having one problem or other. Unfortunately it ripples back and other stuff has to be put on hold. A big piece is due tomorrow (No MLK day break for us!), the final software V&V, we'll see how it looks. Until we have that we haven't been able to finish a lot of traceability documentation and a bit of testing that was waiting for the final software version to be signed off on.

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