Client Quotes  
  "Due to compliance implications for the essential requirements of the MDD and the IVDD, Notified Bodies consider translation to be an 'important outsourced service. . .This makes translation providers subject to the outsourced vendor risk management considerations of ISO 13485:2003 and ISO 14791.' "

- SAE J2450 Endorsement
  KEMA Medical (Notified Body)

 
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Eliminate Distributor Review:
Stop Wasting Valuable Time and Money on Distributor Review

Are you still using Distributor Review (also called "Third Party Review" or "Overseas Review") to satisfy labeling validation requirements? Does your review process get "hung up"—bogged down in a costly, time-consuming back-and-forth between translators and reviewers? If so, Crimson has a solution.

Our patented process for translation risk management has received Notified Body approval as an appropriate substitute for full-document distributor reviews. Many of our clients have already taken advantage of this opportunity to eliminate weeks of time and thousands of dollars of effort from their labeling translation activity—and we can help make your life easier, too.

Contact our Boston or San Francisco offices for supporting documentation or a detailed proposal and stop "managing" your labeling translation
reviews—eliminate them.

 

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