What does that mean?¶
This product is approved as certified medical product according to current legislation.
The software is designed to therapeutically treat limitations that affect the visual field. The loss of visual field is to be compensated by the increased use of saccades.
The product was developed on the basis of interviews with patients and health care professionals (physicians, neuropsychologists, orthoptists and occupational therapists).
On the basis of these interviews, it was precisely defined which requirements the product must meet.
Then the product was developed according to a predefined software development plan.
In addition, the software was tested for various risks: Every person can use the software without hesitation as long as they do not have an acute eye disease (e.g. inflammation) or suffer from photosensitive evocative epilepsy
Risks and the entire product are regularly checked for errors according to a predefined test scenario.
The product has been clinically evaluated: It was found that it is a comparable product in the field of compensatory eye training and it is not necessary to investigate the product with an own study as it is based on a well studied principle.