Carlo Cappelletti

Background

About Carlo Cappelletti

Director R&D at Ascom UMS with an extensive experience on software as a medical device. Planning, execution and delivery of critical application software solutions (used by thousands of users). Design and manage software as a medical device (Class I and Class IIb in EU under MDR, Class II in US, FDA 510(k) clearance). Expert in applicable standards involving medical devices (13485, 62304, 82304, 62366, 14971, 60601-1-8, FDA guidances, IT safety and security standards). One of the first R&D in EU (and Italy) to have released a product with MDR certification. Management and planning of activities for multiple development teams (desktop, web, mobile). Budget management. Product Management hat for many years for the entire Digistat Suite: connectivity with medical devices solution, alarm management solution, PDMS for ICU and operating theater. People Management. Direct involvement with customers during large sales (Italy and EU). Direct involvement in big tenders (Italy and EU). High expertise in training management. Creation and ownership of the Digistat Certification Program. Expertise in the most common training tools. Trainer with solid experience in a multi culture audience (from 1-1 to hundreds of people). High expertise in Human Factor tests focused on risk management. Solutions to collect and manage large amount of incoming data from any medical device connected to patients (infusion pumps, ventilators, monitors, lis, bga, etc.). Solutions to collect and manage data from Wearable devices for hospital and home care. Solutions to exchange data between systems (ADT, LIS, HIS, Pharmacy, dicom). Proven ability to architect and manage next-generation technical solutions (desktop, web, mobile). Designing and managing the transition to containerization domain (all software components running in k8s). Collaboration with healthcare multinational companies: BD, Fresenius, Mindray, Philips, BBraun, etc. OEM product development (BD and Fresenius). Specialties: medical devices acquisition, medical device protocols, high performance data communication, HL7, systems integration, product development, product management, software architecture and design, risk analysis, usability studies, recruiting, regulations, MDR, FDA. Software.NET, C#, Asp.Net Web Forms, Asp.Net MVC, Net Core, WPF, WinForms, GDI+, HTML, CSS, Javascript, Visual Studio, TFS, Sql Server, Git, TCP-UDP/IP Socket, C++, OnTime, SpiraTeam, Jira, Confluence.