Francois Chasseur

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requirements specifications traceability cloud software documentation iso13485 alm qms risk management controlled documents medical devices medical device medical device regulation medical device software medical device requirements management medical device development medical device documentation quality management & control software oem information technology medical health care medical equipment manufacturing alm software qms solutions sxmd management requirements management regulatory compliance digital quality management capa management agile methodology workflow automation integration with tools jira integration github integration azure devops document control technical documentation dhf generation audit readiness iso certifications quality management system collaborative quality culture design controls regulatory submissions user-centric design compliance solutions project management software development lifecycle test case management real-time compliance change management multi-layered v&v testing user stories management data security supplier management dashboard analytics quality audits risk assessment project tracking cross-functional collaboration regulatory technology fda compliance iso 13485 iec 62304 compatibility traceability matrix pipeline automation application lifecycle management quality management systems design control cloud connectivity agile methodologies document management multi-user collaboration integration capabilities fda approvals ce marking global customer base user-friendly interface quality assurance software as a medical device startup support operational efficiency product lifecycle management customer success healthcare innovation regulatory standards secure access rest api document version control technical support user experience hospital & health care information technology & services health wellness & fitness productivity computer & network security ux