Clinical evaluation (MEDDEV 2.7.1)
Medical devices require clinical evaluations to proof safety and efficacy and a critical assessment of the related benefit / residual risk associated with the use of the device: Based on a scientific literature research followed by a systematic gating process the available clinical data have to be analyzed and critically evaluated.
In parallel known adverse event reports published by FDA and European authorities must be rated and reviewed regarding applicable aspects and hints to be considered for the own product.
Clinical evaluation together with the device hazard analysis provide central input for successful proof of conformity.
OPTANA is able to execute clinical evaluations in combination with medical specialists in the respective clinical field.
|Clinical study (ISO 14155)
Planning, execution and monitoring of clinical studies have to follow normative guidelines and require the consideration of ethical aspects. Performance will be controlled at the interplay of the sponsor and the clinical centers (investigator) under permanent monitoring and documentation.
OPTANA has experience in the planning, application at the authorities and monitoring of clinical studies intended to generate clinical data for approval or clinical marketing purposes.