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Thanks to our in-depth understanding of labeling translation risk management and regulatory requirements, along with our unique certifications, Crimson provides custom process development for some of the world’s largest medical device manufacturers. Examples of processes designed to reduce cost and risk for our clients include:

Eliminate In–Country Review – Many manufacturers employ In–Country Review (also known as Distributor or Subsidiary Review) for verification of translated labeling and marketing materials. Based on a Notified Body–endorsed process, Crimson has eliminated this burdensome, costly, and time consuming task for a number of clients. Learn how one company saves hundreds of thousands of dollars annually in a recently published case study.

Labeling Translation Audit – Crimson is the only translation company to hold a Notified Body endorsement for audit of translated labeling. This capability is useful when evaluating legacy labeling translations internally or as part of your due diligence process for a potential acquisition.

Crimson also serves in an audit role for manufacturers who need to manage multiple translation vendors. Crimson’s audit process can provide valuable insight to the quality of translation supplied as part of large-volume labeling projects or workflows.

Outsourced Labeling Updates/Rebranding – Today, manufacturers are struggling to do more with less. Crimson helps clients stretch their resources by offering a host of update and rebranding services. By utilizing Crimson for time-consuming, large-volume tasks, you can free-up your internal labeling resources for valuable, new product development. Crimson’s work in this area has been nominated for industry awards and is employed by several of the largest manufacturers.

Risk-Based Software Validation – Just like the English language original, translated (localized) software is subject to validation. Founded on our experience with risk-based translation models, Crimson designs validation strategies for your localized software that combine risk management and cost effectiveness. Read more about risk-based software validation here.

Multicultural Brand Consulting – Launching your product in the US is tricky — when you add branding considerations in 23 languages, the complexity can be overwhelming. Thanks to the global resources of our parent company, TransPerfect, we can provide you with focus group resources and strategies that ensure you have the valuable “in the field” information you need to create appropriate international brand awareness.

To learn more about our unique processes for labeling translation or schedule a live presentation, click here.

 


Expert Opinion Forum
06/16/2010
Reimbursement Opportunities for Medical Device Manufacturers
11/03/2009
MDD Revision: Are gas pathways subject to the phthalate regulation?
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Bulletins
07/06/2009
New Disclosure Laws for Medical Device Companies
06/09/2009
Crimson Introduces "Expert Opinion" Webinar Series
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Publications
10/01/2011
Top 10 Considerations When Selecting a Medical Device Translation Supplier
09/19/2011
Total Cost of Content
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Industry News
01/31/2012
New Consumer Service for Adverse Event Reporting
12/19/2011
Chinese IP Theft Threatens US Device Makers
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