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Ce travail consiste en l'implémentation d'un eQMS chez Trasis pour les modules "documents" et "training"
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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.
MDR --- VNG --- Clinical evaluation --- RDM --- Sciences de la santé humaine > Multidisciplinaire, généralités & autres
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Systemic AutoInflammatory Disorders or SAIDs constitute rare diseases where the innate immune response is dysregulated. Though there are genes mutations that are associated with monogenic SAIDs, polygenic ones have higher incidence and are more difficult to diagnose. Ambiotis, a CRO based in Toulouse (FR) and with an expertise in the resolution of inflammation hypothesize SAIDs patients have a dysregulated resolution of inflammation. In the context of the Immunome consortium for AutoInflammatory Disorders or ImmunAID, a European Union funded project, a cohort of SAIDs patients was created throughout Europe to collect biological sample. These sample would be analysed by multiple omics techniques to acquire the immunome of SAIDs as a group and as the different diseases. Ambiotis, part of the ImmunAID consortium, quantified Specialized Pro-resolution Mediators (SPM) using UHPLC-MS technique. This master’s thesis goal was to design a pipeline and R library to process the lipidomic data, run multiple pairwise comparison and display results in different graphs format. Our pipeline was able to identify protectin D1 having higher concentration in some SAIDs when compared to negative controls. These results were obtained on the quantified data available; the next step will be to use the entire data set. In the end, we managed to build a pipeline that correct the batch effect, normalize the data and run multiple pairwise comparisons.
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