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Case Study 3: Labeling Support

Situation One of the largest medical device companies in the world hired Frestedt Inc. to provide support for the development of documentation necessary for FDA submission. Engineering support provided to ensure technical aspects of IFU and labeling is ensured.
Frestedt Approach
  • Reviewed 25+ documents (not including review cycles, i.e., revisions)
  • Reviewed governing standards in conjunction with client provided specification documents
  • Provided comments to ensure accuracy in regards to technical specifications
Results Engineering support continues to ensure technical aspects are not overlooked as regulations are changing.

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