Multiple global manufacturers of specialty pharmaceutical products and dental equipment and imaging products required support for clinical documentation, authoring Clinical Evaluation Reports, Clinical Evaluation Plans, and Literature review reports. Clinical evaluations were required for new entries to the market requiring initial CERs, legacy devices and even entire device families. Clinical Evaluation Reports document the results and clinical evidence derived from the clinical evaluation of a medical device and must be a part of the CE technical documentation relating to the concerned device.
The scope of Celegence activities was to create end-to-end clinical evaluation reports. This included creation of the CEP including detailed search strategies for searching device specific literature on scientific databases and adverse events on safety databases, and a robust state of the art review to complement the gathered evidence. The team was expected to summarize all manufacturer held data including claims, non-clinical tests, clinical investigations, and post-market surveillance data. All of the gathered evidence was to be analysed in accordance to Essential Requirements and General Safety and Performance Requirements.