1
Projekt Kick-off
Together we determine the scope and strategic approach of your clinical evaluation. We will also agree a timeframe with you, taking into account your objectives, results and deadlines.
2
First analysis
In the early product development phase, we will carry out an initial evaluation according to the current State-of-the-Art. If this already exists, we will check it and update it if necessary.
3
Clinical Evaluation Plan (CEP)
We prepare a clinical evaluation plan (CEP), including the clinical development plan (CPD), a specification of the intended use, clinical benefit, requirements and relevant parameters for the clinical outcome. Alternatively, we can review and update your existing CEP.
4
Assessment of the state of the art
We evaluate the state of the art for your medical device, including the medical background and possible alternatives. The evaluation also includes the identification of similar medical devices and the quantification of safety and performance parameters. Optimal integration into the documentation of your clinical evaluation is guaranteed.
5
Identification of the relevant data
We develop a literature search protocol with defined inclusion and exclusion criteria. On this basis, we carry out a systematic and unbiased data identification, which includes various scientific and medical databases as well as clinical trial registers as required. All data identification steps are fully and reproducibly documented in the literature search report.
6
Evaluation of the data
We evaluate all relevant clinical data and perform data extraction and quality assessment according to established evaluation schemes (e.g. evidence level).
7
Analysis
We analyze all data with regard to the compliance of your medical device with relevant general safety and performance requirements (GSPR). The clinical data is compiled in a “Body of Evidence”.
8
Clinical evaluation report (CER)
We summarize all activities and data in a Clinical Evaluation Report (CER). Potential gaps in confirming the safety and performance of your product are identified. Depending on the product and life cycle phase, these gaps can be closed by conducting clinical trials or PMCF activities.