Marco Mattiuzzi has a degree and a doctorate in Physics from the Universita’ Statale di Milano. Dr. Mattiuzzi has over 20 years of experience in the field of Research and Development, where he developed a rich experience in fundamental and industrial research. In his many roles, he has helped resolve scientific, engineering, and industrialization problems, providing a broad spectrum of technical expertise. He has led multiple software projects and has worked for Medtech and Pharma companies, including the development of firmware and stand-alone software for Class I, Class II and Class III devices.
Dr. Mattiuzzi is able to consult on all engineering and quality aspects of software development: planning, maintenance, configuration, traceability, risk, and usability, together with unit and system integration verification and validation. He also brings knowledge on the practical aspects of IEC 62304, IEC 82304, IEC 80002 in addition to the specific requirements for software related to ISO 13485, ISO 14971, and IEC 62366. He has also worked on quality system development for medical technology companies to help meet the requirements of the US FDA Quality System Regulation (QSR, 21 CFR 820) and the European Medical Devices Directive (MDD 93/42/EEC).
Dr. Mattiuzzi can help you with: