Thesis, COLLÉGIALITÉ

Abstract

From 26 May 2021, all medical device manufacturers will have to comply with the new MDR regulations. I helped Difra meet these requirements by preparing a clinical evaluation report for its VNG (videonystagmography) and VHIT (Video Head Impulse Test) devices. The VNG is used to assess patients with balance disorders by recording eye movements, as is the VHIT, a sub-test of the VNG, which measures eye movements in response to head impulses in order to assess the vestibulo-ocular reflex. To carry out the evaluation, I conducted an extensive literature search and compared the results with Difra's NYSSTAR I/II for the VNG and the HEADSTAR for the VHIT. In the case of the VNG, I found that frequency plays an essential role in the proper functioning of this device. Similarly, for the VHIT, I analysed the HEADSTAR and identified critical parameters such as frequency, number of head movements, angle of movement, distance between eyes and wall and maximum head speed. However, I discovered discrepancies between the data provided and the frequency and maximum head velocity of the HEADSTAR.