Clinical evaluation of REHATRON™alpha

The clinical evaluation is not only important for the admission and market launch, but also for the following, continual market monitoring of medical products. Each medical product has to prove that it is adequate for the intended purpose and assess the medical risks according to the Medical Devices Act (in German: MPG) §19 clause 1 and attachment X clause 1 of EU guidelines 93/42/EWG, i.e. within the framework of a clinical evaluation on the basis of medical specialized literature, own studies and/or clinical studies. The obligation to make a clinical evaluation is independent from the class of the medical product.

The clinical evaluation is meant to present immanent product and method risks in detail on the basis of the analysis of available clinical data and to make a critical statement on the respective product involving the benefits and risks as well as indicated product features, and of course, the question whether the future user is informed about the use and the risks.

Part or even precondition of technical documentation and conformity assessment it to present the clinical evaluation to the admission board within the framework of admission of medical products of all risk classes, i.e. without an autonomous clinical evaluation admission is not possible.

REHATRON™alpha being the only registered nano-impulse device all over the world and the only officially admitted device for the non-invasive induction therapy has a comprehensive clinical evaluation and a positive assessment consisting of clinical studies and assessments and medical specialized literature.

Due to the restrictions of the Law on Advertising in the Health Care Service (in German: HWG) we are not allowed to make the clinical evaluation and assessment for REHATRON™alpha accessible for our visitors in the public area of our website. The complete clinical evaluation which is only valid for REHATRON™alpha is accessible for doctors and persons from non-medical professions in the secure log-in area.