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.