3.0 Clinical Trial.
Clinical evaluation by clinical examination of medical devices
We have decades of extensive experience as LCP with clinical MPG tests up to class III / active implants. The fulfillment of clinical trial requirements for medical devices can be supported by Prof. Zenner and Partners through the creation of an Investigator's Brochure as well as by providing patient education and consent information. In addition, advice on the preparation of the test plan in accordance with DIN EN ISO 14155 and the clinical evaluation of the results can be provided.
The DIMDI application for clinical trials.
The clinical evaluation office Prof. Zenner can support the DIMDI application for clinical trials and contribute to the completeness of the application documents.