2019. 12. 04. Precisely Write, Inc.

- Medical Device Documentation

Contact us: info@precisely.com

1-800-985-7701

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Medical Device Documentation

We are experts in medical device-
related documentation
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We have many years of experience Content—what is it
developing documentation for medical and why manage it?
devices and medical diagnostic So you think your
equipment. We understand FDA 801 company has nothing to
guidelines and requirements for product do with producing
labeling. We are experienced with content? Pamela Kostur
complex electromechanical devices and shows you how all
companies produce
related software.
content from user
guides to employee
We know how to "Write it, Right" when it handbooks and all
comes to: companies need to
manage it.
Instructions for Use (IFU)
Patient Manuals On the trail of the
Clinician Manuals next killer app
Quick-reference Guides Learn the three
concepts of Content
Quick-start Guides Management and how
Setup and Installation technical writing has
Manuals morphed—yet again—
Service and Maintenance into this new field.
Manuals and Procedures
Medical Device Software
Documentation including
online help systems
Directions for use
Inserts
Click here for details
We also have Quality and Regulatory
Compliance experts who can assist you
with

510K submissions
Specific FDA labeling
requirements
cGMP and ISO requirements
and documentation

We are experienced with the software

you use, including Adobe®
FrameMaker® and InDesign®

We have writers who can do the research

(Literature Route and/or Clinical
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2019. 12. 04. Precisely Write, Inc. - Medical Device Documentation

Investigation Route) and develop your

Clinical Evaluation Reports (CERs).

We also have experience developing

Commissioning and Qualification
(C&Q) Validation Documentation.

Having one company with the expertise to

handle all the above lets you benefit from
our team approach. Our writers can easily
work closely with Quality and Compliance
experts to ensure you get the best
outcome.

We also understand while you can fullfill

the basic requirements that often doesn't
mean the patient, medical professional, or
lab worker is getting documentation that
is easy to understand or use. Many
companies' help lines are overused
because their documentation is simply
not being read because either the
instructions are too difficult to follow or
the information needed isn't readily found.
We understand that and we draw upon
our experience to develop and design
documentation that is both easy to use
and understand. Depending on the scope
of the project, we can work with your
human factors consultants or our's, and
engage focus groups to ensure you are
getting the best possible documentation
through testing and verification.

If your products reach global markets,

rest assured we also have the experience
with translating and localizing
documentation into as many as 21
different languages.

We can also develop training materials

and marketing-related documention for
your product.

Contact us at info@precisely.com for a

free consultation. Or call 1-800-985-7701.
We will show you how to improve your
content processes–and increase your
productivity.

If you prefer, please feel free to fill out the

form below and someone will contact you
promptly.

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2019. 12. 04. Precisely Write, Inc. - Medical Device Documentation

Full Name *
First Name

E-mail * ex: myname@ex

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Area Code P

Company Name

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State/Province *

Country * U.S.

Please briefly
describe your needs
(i.e., deliverables,
special skills needed,
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requirements,
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2019. 12. 04. Precisely Write, Inc. - Medical Device Documentation

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