Nov 29, 2007

The Operator's Manual

I've been working on the dreaded Operator's Manual lately. I have all the important stuff in there, now I'm going to cram it full of useless information until it is twice as thick as it is now. The Operator's Manual is part of labeling and a nearly complete draft is required for FDA 510(k) submittal, some testing labs require one before they do certain testing as well. Writing it has ended up taking a lot more time than I had planned because I know no one will really check it out for quite a while. A couple people will read it of course and have a few comments, but unless I really push hard no one will go through it step by step. Which must be similar to how most other companies do it because I have seen a lot of bad manuals out there.

Things are going pretty well (knock on wood) lately, we even got some critical things done by outside vendors during Thanksgiving weekend. The key seems to be large cash payments. We do have a Dec 31 deadline coming up, I'm not sure who decided that was a good idea. Apparently many MBA programs skip over some basic facts about holidays.


Roger said...

At my company QA performs every step (that they can in their lab) of every procedure in the manual. They also have an inspector read through everything for spelling and verifying cross references. Our devices are used by physicians that rarely read them. It seems most of our efforts are to get the PMA through FDA.


JCK said...

We once did a physicians training session on our equipment, took 9 manuals in to pass out during the training. All 9 were left in the room when it was over.

Milan Davidovic said...

If you do a Google search for "operator's manual" fda recall you can find some instances of medical devices being recalled because of problems with operator's manuals. So, doing a good job on them can make a difference.