The medicinal device – guideline defines what is required from the producers of medicinal goods. Among others, standards are specified regarding the conformity evaluation of medicinal devices. Within the DIN EN 60601 and 62366 norms, defaults are defined regarding the safety and usability of these products. All of this leads to an increased focus on user safety and usability as far as it concerns medical devices.
Our human factors experts assist you in complying with these requirements and accompany your development project by, amongst others:
HFC is currently working on a project sponsored by Federal Ministry of Education and Research called BioLED; in cooperation with the OUT e.V. and the Humboldt University Berlin, we develop an individualized phototherapy aiming at increasing vigilance and compensating for temporary phases of fatigue. Through application of pulsing light with highly limited wavelength, the vegetative nervous system can be influenced directly. To achieve this, a precise adaptation to the specific user and his current state is required; this can be done by online measurement of the heart rate and the adjustment of pulse frequency and wavelength to the user’s condition.
Two applications of the procedure were prototypically realized up until now: the first one is dealing with using the phototherapy in the context of driving to reduce fatigue; for example, if a fatigue detector measures high levels of fatigue, a strip light of LED emitters administer the signals . The second application revolves around administering the signals with the help of specially prepared glasses.