Ugo TOMAS

• Led risk activities, including risk assessment, management, and usability, during Phases 1, 2, and 3 for an electronic medical device (Class II/IIa) in accordance with ISO 14971, IEC 60601, and 62304. • Led the completion of DHF documentation throughout the various phases of the new product. • Led the progress of the Compliance Matrix, identifying actions to demonstrate compliance with regulatory standards (EU & USA) • Managed change control evaluations and developed action plans. • Coordinated lifecycle activities for a CE-marked electronic medical device. • Supported the team in conducting usability assessments through hospital staff interviews. • Supported the team in characterization processes for cleaning, sterilization, and V&V to achieve Phase 4 completion. • Facilitated relationship development with potential new manufacturers. • Acted as responsible for the Technical File during the submission of the medical device for an IDE study (FDA) and MDR submission (EU).

• Managed the NC in the metrology department for Class III implantable medical devices (shoulder, elbow, and hand). • Created and Revised SOPs & WIs to apply Stryker processes to the new acquisition of the Thornier SAS site. • Monitored CAPAs. • Managed deviations. • Implemented a Metrology training and the use of Inspection, Measuring and Testing Equipment (IMTE) for 150 people. • Established admission and availability process for IMTE.