1
Projekt Kick-off
Together we will establish the scope and strategic approach of your Clinical Evaluation. We will agree on a timeframe with you that respects your milestones, desired outcomes and deadlines.
2
First analysis
In the early product development phase, an initial evaluation according to the current State of the Art will be performed. If a State of the Art document is already available, we will review and update it, if necessary.
3
Clinical Evaluation Plan (CEP)
We will create a Clinical Evaluation Plan (CEP), including the Clinical Development Plan (CPD), a specification of the intended purpose, the clinical benefits, claims, and relevant clinical outcome parameters. Alternatively, we can also review and update your existing CEP.
4
State of the Art Evaluation
We will evaluate the State of the Art for your device including the medical background and alternatives. The evaluation also includes the identification of similar devices and the quantification of benchmark parameters. Seamless integration with your Clinical Evaluation documentation will be ensured.
5
Data identification
A literature search protocol including defined inclusion and exclusion criteria will be developed. Based on this, we perform systematic and unbiased data identification, which include various scientific and medical databases as well as clinical trial registries, as required. All data identification steps will be comprehensively and reproducibly documented in the literature search report.
6
Data Appraisal
All relevant clinical data including data extraction and quality assessment according to established assessment schemes (e.g. level of evidence) will be appraised.
7
Analysis
All data will be analyzed regarding compliance of your medical device with all relevant General Safety and Performance Requirements (GSPRs). The clinical data will be collated into a body of evidence.
8
Clinical Evaluation Report (CER)
All activities and data will be summarized in a Clinical Evaluation Report (CER). Potential gaps in confirming the safety and performance of your medical device will be identified. Depending on the device and the lifecycle phase, those gaps can be closed by performing clinical investigations or PMCF activities.