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GLC Can Help You with IVDD and MDD Compliance
As of December 7th, 2003 all in vitro
diagnostic medical devices (IVD) sold within the European Union
must carry the CE Marking. The CE Mark is a "certificate"
indicating that the device is compliant with all rules and regulations.
This directive also includes local language requirements. Additionally,
MDD (Medical Device Directive) that was adopted on January 1, 1995 has
similar mandates for general medical device manufacturers.
Failure to comply with IVDD or MDD and sell products in the European Union
without a CE mark may have significant ramifications. The
manufacturers of such products may face criminal charges as regulatory
authorities pull their devices off the shelves.
GLC's experienced medical translation and project team can help you meet
IVDD and MDD compliances and sell your products confidently with a CE
Mark affixed on them. Advantages of partnering with us for your language translation
needs include:
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Expert certified
medical translators in all languages
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QA process to deliver
flawless translations
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Experienced project
managers to answer all your questions
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FREE glossary compiling
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Liaison with your
reviewers
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Timely delivery to meet
your deadline requirements
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Discounted rates to
meet your budgets
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FREE certification of
translation
Call us today at (312) 275 0465 or send us an
e-mail at glc@e-translation.com to discuss your CE Mark, IVDD and
MDD compliance needs.
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