American regulation (FDA) and Canadian regulation (Health Canada) for Medical Device, classification II (IIa in France)Created a pre-submission (Q-sub) to a 510(k) for a class II Medical Device and mailing to FDADeveloped the usability engineering file for the CE markCreated the state of art of the chapter III of the Annex I about requirements regarding the information supplied with the device (MDR 2017/745)Maintenance of the risk management recordParticipated to the PIA (Privacy Impact Assessment) of a clinical study : AIPD Analysis of the privacy impactStandards : ISO 62366-1, ISO 14971, ISO 13485Concepts approached : Quality Management System, Directive 93/42/CE, new European Medical Device Regulation (EU) 2017/745 (MDR)

Industrial project during my last year at ESIR in collaboration with THERENVA (group of 3 students).THERENVA develops software tools for cardiovascular procedures.Nature of the need: access for doctors to the functionalities of EndoSize on different platforms.Choice of a web interface, intuitive, accessible and practical for the user.Development of a proof of concept for a vascular intervention planning tool using web technologies:Endosize functionalities via a web interface (Javascript, NodeJs, HTML, CSS)- State of art of the technologies- Development of the functionalities- Performance analysisOur project received the 2019 innovation award from the Foundation Rennes 1

Developed of a solution allowing the transfer of sensors data from a connected medical bed to an interface dedicated to caregiversNeeds study and sensors studyProgramming of an on-board electronic card in C / C ++ languageCreation of MQTT server and implementation of the communication between the electronic card and the serverTechnical environment : GitLab, GitKraken, NUCLEO-F207ZG card, IDE mbed, Visual Studio code, Linux

Orange Labs,Developed a cloud Android application in Java

Developed an algorithm which extracts nodes and terminations of an arterial tree to help in the radioembolization of liver tumors