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Risks and Rewards
Alliance Helps Medical Device Manufacturers Manage the Costs of Going Global
For immediate release
April 17, 2003
Further Information:
Kristen Giovanis, 612-288-9494
Minneapolis -- Bring a medical device to
market in the United States, and you’re in for years
of research and development, clinical trials, published research
and effective marketing.
Bring the same device to market globally, and the time and
costs involved mushroom exponentially.
A new alliance between two Twin Cities firms helps manufacturers
navigate the maze of regulations and manage the costs involved
in taking devices to the global market. KJ International, a
full-service translation firm, and RCRI, a contract research
organization specializing in medical devices, IVD and biomedical
technologies, will jointly contribute to the success of medical
technology companies worldwide.
KJI offers business-savvy translation services through an
international network of in-country language specialists. RCRI
offers clinical trial, regulatory strategy/submissions, quality
compliance and consulting on minimizing the costs and risks
associated with bringing a technology into overseas markets.
Medical technology is subject to a dizzying
array of site-specific regulations and requirements. By combining
their expertise,
KJI and RCRI offer clients a unique advantage in compliance – knowledge
of how much is enough, and how to get it done right the first
time.
“European law mandates that certain documentation and
labeling be translated; every country has its own requirements,
and translation alone can get very expensive,” notes
Kristen Giovanis, Managing Director of KJI. “How do you
meet all those standards in a cost-effective manner? By working
with translators who understand what you must do to be in compliance
and thus manage those costs.
“Our alliance with RCRI helps our clients go several
steps further in determining the best way to bring a technology
to a new market,” Giovanis adds.
Steve Norsted, President of RCRI, says: “With
this alliance we bring together worldwide expertise and the
seamless delivery
of services for each phase of medical product development to
facilitate global market access. Wherever in the world our
clients want to take their business, we can confidently refer
them to KJI for their translation needs and know they will
get the same degree of expertise in language consulting that
we provide in medical device consulting.”
***
About KJI:
KJI: We Speak Your Mind. KJI is a full-service translation
firm bringing together state-of-the-art technology and business-savvy
language consultants to help clients of all sizes communicate
effectively across language and cultural barriers. With clients
in medical, software, industrial manufacturing, legal and scientific
sectors, we do more than find the right words; we help clients
navigate cultural differences, regulatory requirements and
international law. Our capabilities include print, graphic
design and layout, web translation and localization, conversational
and group interpretation, voice-overs, and more. For more information
on KJI, please visit www.kjinternational.com or call +1.612.288.9494.
About RCRI:
Since 1999, the Regulatory and Clinical Research Institute,
Inc. has been supporting the medical products industry with
clinical study design and management, healthcare outcomes
research, regulatory strategies and submissions and quality
systems and compliance. For more information about RCRI’s
services, please visit www.rcri-inc.com or call +1 952 746
8080
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