In-Vitro Diagnostic Products
Translation & Localization
Our clients that manufacture in-vitro diagnostic (IVD) products understand all too well the challenge that regulatory requirements can pose. They also understand the need for a localization partner with the experience and expertise necessary to help them successfully navigate the ever-evolving language requirements in the established markets of the EU or in the emerging markets of Asia, Latin America or even Africa.
For many of our clients who wish to market their IVD products in the EU, a crucial step is attaining CE Marking approval. But CE Marking approval is just a beginning, as concerns of translation, packaging design and distribution must also be managed in a manner consistent with the IVDD. Depending on how certain individual European countries choose to interpret the EU IVD Directive and where they choose to set the bar on in-language requirements, a cost/benefit analysis needs to applied before the decision to enter a given market is reached. Our life sciences practice group has professionals who can help. Whether determining the language groups that will give you the best return on your investment, designing a multilingual layout for overseas distribution, or providing effective online support for your international product line, Translations.com offers a full suite of globalization solutions to get you into foreign markets quickly, with quality that you can depend on to clear any regulatory audit.
Clients seeking the CE Mark should be keenly aware of the potential avalanche of material for which localization might be required, including user documentation, packaging & labeling, regulatory submissions or even intellectual property documentation. Translations.com can help you to get your arms around the endeavor, and can offer strategies to minimize costs by enabling you to leverage all of your localized assets, use symbols where possible and provide your workforce access to translated material on-demand.
In-Vitro Diagnostics Client List
We're honored to serve some of the world's leading corporations. If you'd like to learn more about Translations.com client solutions by examining a case study, please click one of our highlighted clients.
- Abbott Laboratories
- Becton, Dickinson & Co.
- Dade Behring
- Quest Diagnostics