Giuseppe Trovato Email and Phone Number

New Product Development, R&D Manager

Since May 2016 I have been appointed as Project Manager of the Sorin CONNECT SW. In this role I’m responsible for all the projects of the SW Sorin CONNECT in terms of scope, time, quality and compliance with standard.As PM I’m actively working to:• clear communication between all the stakeholders, • scope of each SW release,• provide support to definition of the business case, • define plan for worldwide submission, • define project plan including project risks• creating WBS for proper estimate and planning,• manage the change requests, • support the R&D functional team for resource allocation over several projects that are managed in parallel, • coordinating the communication and the definition of milestones with the external suppliers,• monitoring the status of the development according to the Design Control procedure, Software Development Procedure, Risk Management and Usability,• responsible for the communication to the upper management about the status, the risks and the next step of the projects.In particular the scope of the SW currently under development is related to a new functionality that will allow Sorin CONNECT to be able to communicate with the Hospital Information System via HL7 protocol.In this project I’m leading a continuous improvement of quality standard, by enabling compliance with standards, introducing new process for SW anomalies management, introducing code inspection, enhancing test methodologies, and improving the application of the overall lifecycle model. This activity results in creation of new templates, new procedures and enhancements of existing ones.I’m also leading the compliance with Design Control procedure, Risk management procedure and Usability and Human factor procedure.

Since November 2015 I have been appointed as Project Leader for the redesign of the Datapad III, the medical device geared with Sorin CONNECT. In this activity I led a multifunctional team (R&D, RA, QA, FS, MFG, MKTG), including an external non-medical supplier, with the goal to complete the redesign according to the agreed plan, including the creation of a dedicated DHF set in order to allow worldwide submissions of this device and to qualify the device as medical grade.The project has been successfully concluded in June 2017, according to the scheduling.The project has successfully and on time, submitted to FDA for a 510(k) clearance.The project has recently (October 2017) successfully passed a TUV audit related to Design Control and Design Change.

- Management of Design History File, according to ISO 13485, FDA Guidances, IEC 62304, IEC 62366- Risk Management according to ISO 14971- Development of SW for Medical Device according to IEC 62304, IEC 62366: User Interface for Datamanagement System Sorin CONNECT for perfusion data trending, C#/WPF based, and User Interface for Autotransfusion equipment, C++ based- According to the above mentioned standards, I'm involved in the entire lifecycle: - supporting definition of User Requirements, - definition of Design Input, - Risk analysis, - Interaction with Regulatory Affairs, Quality Assurance for regulatory and Quality requirements definition, - Software Requirement Specification, - Software Design Specifcation, - Verification activities including plans, protocols, test methods, - Validation of SW and Electronics tools

Design Input Requirement analysis, Design of the control unit software component for diesel injection, Testing and validation of the control system for Electronic Control Unit of a Diesel Engine.