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I hope that this email will be helpful, though it may get to you a bit
late.
I have worked 10 years in the medical device industry and one of our
major requirements was FDA comliance.
Writing for medical devices involves the following major issues:
1. Knowing what the FDA requirements are and how they apply to your
device. For this you need a good working relationship with the
regulatory dept. They are responsible for providing you with the
relevant information and how it applies to the device.
2. Writing EVERYTHING from the point of view: Does this comply?
For example: If a customer asks for step by step instructions on
how to place a catheter in the patient's heart - this does NOT comply
with FDA requirements. From the FDAs point of view - this is telling the
doctor how to be a doctor.
However, you can RECOMMEND certain approaches towards navigating
the caheter.
A lot of this boils down to making sure you are using the right
terms, and that there is no way anything can be construed to mean
something else. Lots of fun.
3. You may be asked to help with the actual file. Important issues?
Product name, and the claims for the device, which must be backed up
with solid evidence. When you write your manaul - you have to be very
certain that no claims are made that were not initially in the FDA
approval. In some cases you may have to use the exact wording that was
used in the approval (even if the wording is bad and unacceptable).
4. In some cases you must write disclaimers and include footnotes to
information, based on the FDA's response to the approval. If you want to
change the wording - get it approved by Regulatory - in most cases you
won't be able to change the wording.
5. You will need to be aware of every part of your documentation that,
if changed, needs to be brought to the attention of regulatory - whether
or not the product manager agrees. In the fast paced medical device
industry, especially if you are documenting a system, it is possible for
changes to be entered that regulatory has not yet been advised of. A red
flag word to watch out for is "accuracy". Any feature of a medical
device that you must document, and it relates to some type of
clincial/medical/device accuracy must be brought to the attention of
regulatory. Very often changes are implemented that the developers
really are clueless about - but the final implication can be serious. So
when you become aware of something, you make sure you know the PM,
Regulatory, and other relevent SME's know.
Finally, medical device documentation is the most rewarding - because
you know - even if no one reads the manual - your manual is a critical
element of the device's acceptance to market, and ultimately, when it's
an effective device, contributes to the quality of life of patients
needing the treatment modality offered by your company's device.
I hope this info gets to you in time.
Good luck!
(and if anyone knows of a company needing these services in the Grand
Rapids area, let me know! I'd enjoy getting back into it...)
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