CLINICAL EVALUATION

The evaluation of clinical data is not only of prime importance for the official approval process and product launch, but also for the continuing market surveillance in the field of medical devices... According to appendix X § 1 of the EU guideline 93/42/EEC as well as according to most national legislation regarding medical devices, suitability for the intended use has to be established for all medical devices and an evaluation of medical risks has to be conducted. These provisions are met by means of an evaluation of clinical data based on scientific literature, research and testing and/or on the basis of clinical studies. A clinical evaluation is required for all classes of medical devices.

VAT numbers: DE 244628695

Primary location: Birmingham United Kingdom