Clinical Evaluation Process

Ensuring compliance with the Medial Device Regulation (MDR) in the changing medical device environment means having a complete and current clinical evaluation report (CER).

BBA’s team of regulatory, clinical affairs, physicians are skilled at writing quality clinical evaluation reports that are consistent with regulatory expectations. A team comprised of the Senior Medical Director, Medical Writer and Clinical Director at BBA are here to help write CER’s.

Commonly a CER Includes

  • Technical device description and intended application
  • Intended therapeutic or diagnostic claims
  • Patient Populated Treated
  • Clinical evaluation and data types
  • Summary and appraisal of clinical and other data
  • Description of analyses used to assess product literature and other data sources
  • Conclusions about safety and performance
  • Recommendations on changes to labeling and risk management files
  • Post market surveillance plans for subsequent C

Approach to Writing CER’s

CER Process

With BBA writing the CER for your medical device the result will be a well written, scientifically valid, regulatory compliant, high-quality document that can also be added to the technical file.

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