Competence support - Clinical evaluation report

Purpose and goal:

The competence enhancement will help us to create a Clinical evaluation report.

The project is to be carried out in collaboration between the staff at Neosense and the consultant who assists with expert competence in the field. The evaluation report must be compiled from a scientific perspective and based on the intended use of the product. The evaluation must clearly demonstrate the safety and performance of our products, and justify the clinical benefits when our products are used as intended.

Expected results and effects:

The expert supports us to,

- planning and structuring the work,

- search for scientific data in databases,

- assess which data are relevant and useful in the clinical evaluation,

- analyze scientific data and draw the right conclusions,

- analyze the product´s safety, performance, and benefit/risk profile,

- and create the Clinical Evaluation Report.

The purpose of this support is to create a clinical evaluation report that is compiled in accordance with the requirements of the regulations.

Approach and implementation:

The project is to be carried out in collaboration between the staff at Neosense and the consultant who assists with expert competence in the field. The consultant supervises the work and also actively participates in editing and reviewing the clinical evaluation report.