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As one relatively new to a biotech company, I can sympathize with your
questions.
There are two types of applications: clinical and research. Clinical are
much more regulated by the FDA; however, clinical ones do fall under some
restrictions. And to confuse things more there is research and clinical
research. Clinical research falls under the "clinical" category. The
applications themselves completely depend on the equipment. For example, my
company works in flow cytometry and many of the applications deal with
cancer research.
The documentation also depends on the type of "stuff" the company has. My
company releases reagents, which require data sheets (for research
products) or package inserts (for clinical products). They also manufacture
instruments (big computers and machines) and software to run on them. So I
deal with a wide variety of documentation.
Most people seem to still desire printed docs. However, many companies
seem to be providing only the basics as printed, and the more substantial,
reference stuff is electronic.
Unfortunately, this is a bit vague, but there is soooo much variation,
it's hard to be specific. I would recommend asking the company what type of
documentation they expect.
Good luck!
Christi
>Hi,
>
>Can anyone tell me what "clinical applications" are, in reference to writing
>documentation for new medical equipment?
>
>Also, for equipment such as cardiopulmonary or ultrasound, can you tell me
>what type of documentation is typically required from the technical writer,
>and whether it is typically print, online or both?
>
>TIA,
>D. Crossman
>DLCrossman -at- aol -dot- com
>
>
>From ??? -at- ??? Sun Jan 00 00:00:00 0000==
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Is it better to have words left unsaid,
than to have words misunderstood?
- Cowboy Junkies
