Regulatory Representation

CSSi LifeSciences™ has the necessary knowledge and experience to guide clients through a broad range of regulatory activities, including:

  • FDA Establishment Registration/Device Listing activities
  • EU Authorized Representative for CE Marked devices
  • FDA US Agent for Foreign Establishments
  • Authorized Representative for Medical Device Trials in Europe
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To obtain approval in the EU, medical device manufacturers must document through a clinical evaluation report (CER) that the product is safe and effective, while proving that the product is similar to an approved device. CSSi Life Sciences’ experienced staff provides guidance to prepare a CER that addresses all evidence required to ensure approval, including:

  • Choosing the correct predicate device
  • Designing the appropriate clinical or preclinical study
  • Analyzing the data
  • Preparing the study report
  • Submission to the EU authorities