Technical Writing in the Medical Device Industry

[Naomi L Burnett <burn1729 -at- fredonia -dot- edu>]

Hi everyone,

Do you have any suggestions of books, blogs, or other resources that would
help a beginning tech writer in the medical device industry?

To give you a little background (if it will help), I began a job as a tech
writer in the medical device industry a few months ago at a very small
company. I'm new to everything about this job; I have my Master's Degree in
English Literature, and this is my first tech writing experience.

So far, on the job, I've written a draft of the quality manual (using
general Internet research, a retracted FDA manual on quality systems that
my boss saved, and of course 21 C.F.R. part 820). I'm now working on the
standard operating procedures for the quality system and researching how to
write a 510(k) for a new product.

I would love any advice you experienced tech writers might have about tech
writing in the medical device industry, and I would especially appreciate
any titles of (or links to) research resources that might be of help for my
research.

Thank you so much!

Naomi
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