1. LaunchReady
Docs
Does your company have an aggressive product launch schedule? Is translation taking
up more time and budget with each successive project? Are you experiencing a prod-
uct recall, have you been given an FDA consent decree, or do you have regular audits?
As medical device companies continue to innovate and compete for market share,
documentation and translation needs for new products keep flooding in. On top of that,
translation needs quickly swell to meet the demands of the global marketplace. This
tidal wave delays product launches and gives the advantage back to your competitors.
Additionally, stringent FDA regulations make quality systems documentation an
increasingly time-consuming and important task. Given the significant financial
ramifications of a product recall for failing an FDA audit, falling behind on your quality
systems documentation is not an option.
The industry’s best realize that a holistic, best-practice documentation process is
the most efficient way to control costs without delaying product launches or risking
product recalls. Ride your current with a single-source environment and watch the
return on investment soar!
Novatek’s Medical Device Product Documentation
Novatek will plan, design, develop, produce, and maintain your documents so you can
focus on your top priorities! Novatek provides documentation that is error free and on
time, including:
IFU’s
Labeling
User Manuals
Service Manuals
Translation
Novatek’s Quality System Process Documentation
In the highly competitive medical device marketplace, the financial ramifications and
time lost to an FDA audit or consent decree can have tremendous impact on your
company’s bottom line. Novatek’s Quality Systems Process Documentation is a cost-
effective option to keep your organization’s process documentation up to date and
compliant, including:
Standard Operating Procedures
Workflows
Work Instructions
Launchready Docs for Medical Devices
Benefits
Meet product launch dates with writers
experienced in the medical device life
cycle.
Ensure compliance with writers
experienced in FDA regulations.
Shorten your time to market with
writers experienced in chemistry,
imaging, immunodiagnostics, and more.
Lower translation costs by leveraging
the industry’s best technologies.
Author your documents in one format
for multiple outputs (web, print, CD, etc).
Build customer loyalty and differentiation
with concise & user-friendly documents.
Avoid the risk and devastating financial
ramifications of failing an FDA audit.
Contact: Randy Ladd 585.482.4070 Randy.Ladd@novatekcom.com novatekcom.com
Customer Quote:
“Novatek’s experienced writers understood
how to extract the most important knowl-
edge, express it concisely, and gain final
approval from our engineers. Novatek has
routinely helped us gain FDA compliance
and reach our product launch goals.”
Louise Remington,
Department Lead, Technical
Communications and Translation,
Carestream Health, Inc.