Clinical Evaluation Reports (CER) have become, and will continue to be, the capstone of a medical device's design history file. We can assist you in:

  • Generation of CER for compliance with the Medical Device Directive Annex I & Annex X.
    • We can provide assistance from initial literature searches and MDR reviews through to the complete end product analysis.
    •  We go beyond the Annex X requirement for a Clinical Evaluation Report.  According to Annex I requirements, we prepare a review of the overall risk benefit of the device given how you design/make/label/transport your product, how your customers use it and the target patient population.

  • Training staff as to:
    • The requirements of and interdependence of Annex I:  General Requirements and Annex X of the Medical Device Directive.
    • The FDA's requirements for risk analysis.
  • The generation and maintenance of CER.
    • Establishing the procedures for CER generation:
      • The identification of harms/hazards.
      • The processes for the identification, selection and processing of articles from the medical literature.
      • Developing procedural links between the process that generates your CER and your complaint system and post market surveillance.