Clinical care plan
What do you want to achieve: Medical device, DiGA (Digital Health Application), both? What are the functions and claims / positive care effects of your device? What resources do you have and what else do you need?
To address these questions and to clearly structure and define the further steps, we have developed the Clinical Care Plan. Together with you, we work out the health-related effects associated with the application and make these usable for further monitoring of the certification / approval as well as regarding compliance with the corresponding prerequisites and regulations. The preparation of the clinical care plan is elementary in order to steer the monitoring process in an orderly manner from the very beginning, to benefit from the synergies and to completely avoid later rework if possible.
Preparation of the necessary documentation
Our range of services includes the provision and preparation of all documents required for certification / approval. This includes the clinical evaluation plan (CEP), the clinical evaluation report (CER), as well as the Post Market Clinical Follow-up plan and report (PMCF plan / PMCF report) as part of the technical documentation. In the case of a DiGA we, as a manufacturer-independent institute, are also qualified to prepare the evaluation concept. In the course of this, we can also undertake the necessary systematic literature research on safety, performance and state of the art for medical devices and in the context of systematic data evaluation for DiGA.
Proof of positive care effects
For the approval of a DiGA, proof of medical benefit and / or patient‑relevant structural and procedural improvements must be demonstrated in every case by means of a clinical trial. Such a study may also be relevant for medical device certification in the context of CE marking or for PMCF activities. In this case we will gladly find a suitable CRO for you and support you in an advisory capacity during study planning and execution. In doing so, we also check compliance with regulatory framework conditions (ISO 14155 / ISO 20916) for the study and in preparation of corresponding documentation.