Literature-based Clinical Evaluation
With a clinical evaluation, you as the manufacturer prove the medical technical capability of your medical device. In other words: You provide evidence that the product actually delivers the medical benefit you promise in product information material and advertising.
A clinical evaluation is based on clinical data from scientific literature and/or from own data acquired in clinical investigations. It is part of the technical documentation and must be presented for the approval of any medical device regardless of its risk class. In the evaluation process, the benefit expected from the application of the medical device according to its intended use is measured critically against the results from risk analysis, the state of the art, clinical standards, as well as the knowledge collected from scientific publications.
The aim always is to confirm the clinical efficiency and safety throughout the expected life cycle of the medical device and to verify that the identified risks are justifiable in relation to the clinical benefit.
Clinical evaluation is complex and the process requires a considerable amount of time. Commission our experts with parts of the process or the complete package and we will take care that you can concentrate on your core competencies meanwhile. Furthermore, we suggest suitable strategies for the future, so that you may keep your documents up to date without having to invest a lot of time or manpower.
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"Our primary aim is not to develop a one-time clinical evaluation for you. We put you into the position to keep the documentation of your clinical evaluation up to date in the future across the entire product life cycle with the lowest possible effort in terms of time and personnel."