Clinical Evaluation Profundus AB

Purpose and goal:

Profundus is an innovative company that develops and markets an instruments for capturing high-resolution images of the retina. Profundus´ product is classified as a medical device product, class IIa and needs to be certified according to the MDR before a CE mark. Profundus has received help and knowledge to prepare a clinical evaluation, an important step before the clinical study that brings us closer to a final CE marking of the product.

Expected results and effects:

Clinical evaluation is a systematic process of continuously generating, collecting, analyzing and assessing clinical data to verify the safety and performance and clinical benefits of the product. It is carried out throughout the life cycle of medical devices, as a continuously ongoing process. Therefore, the knowledge needs to be built and available at Profundus.

With help of this project, Profundus has partly received clear answers in the existing phase and also built a basis for how this work should be done in the future. Approach and implementation: The work is done as follows: Planning the clinical evaluation. Identification of relevant data. its benefit/risk profile.

Looked at residual risks and whether these are acceptable for CE marking. Support to summarize relevant clinical data. Compile final information to plan the clinical trial. Increased understanding of relevant documents to the technical file.