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We have 6 TW's and are constantly busy. All of us had
some prior TW experience before being hired, but none
of us have any specialized medical knowledge.
We employ a multi-stage review process that includes
specialists from medical, legal, regulatory affairs,
marketing, engineering, technical services and
quality.
But before we get to the formal review process we
constantly vet our work within our product design team
meetings so that we have no glaring errors that are
perpetuated from section to section.
One example of my recent work is a maintenance manual
for a bed product that has been in development for
over 3 years. In the manual are several technical
procedures that I wouldn't have a clue about right or
wrong. But working with the engineers that designed
the software and hardware, I watched and asked
questions as they actually did the procedures and
recorded the process step-by-step. After I wrote the
procedure out, I vetted it with the engineer or
technician for correctness and made any changes
necessary. (Often there were none.) Then the
procedure was validated by a technician that had
nothing to do with the original demonstration/writing.
Once it passed that validation, it was good to go in
the manual.
The thing to keep in mind about writing for a medical
products company is the amount of government oversight
and product liability issues. Nothing gets published
in a users guide, operations manual or maintenance
manual without it being checked 7 ways from Sunday. I
find it sorta sad that the final say-so goes to legal.
No matter what one of the other departments want
included in the manual, if legal says no, then that's
the final say. Sure glad we're on a first name basis
with the lawyer. ;-)
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