First, we work with you to define the scope and strategic approach of the clinical evaluation and agree on a timeframe, including any deadlines that must be met. The exchange of all necessary information takes place.
In the early product development phase of the product in question, an initial evaluation is carried out according to the current state of the art. If this already exists, it is checked and updated by us.
We then create a clinical evaluation plan (CEP), including clinical development plan (CPD), or update the existing CEP according to the lifecycle phase and update needs for your medical device.
We search literature and guideline databases for information on the medical background, similar medical devices and medical alternatives.
We identify clinical and generated non-clinical data for your product and fully document our database searches. We also include data from clinical trials that have been conducted.
After extensive data identification and literature search, we perform data evaluation, including data extraction from scientific publications, and quality assessment (e.g., level of evidence).
Our analysis also includes evaluations regarding the relevant General Safety and Performance Requirements (GSPRs) of the medical device under evaluation, as well as grouping the data into a Body of Evidence for the device under investigation.
Finally, all activities and data are summarized in a Clinical Evaluation Report (CER). During development, the CER helps to identify any data gaps and to plan clinical trials if necessary. For conformity assessment (CE marking) of the investigated product, the CER is updated and sufficient data must be available to demonstrate safety and performance. An (annual) update of the CER to include new data from PMS/PMCF and other sources or when design changes are made is also performed.