Enrico Enrico Altini Altini
R & d and Technical Director @Angiodroid
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WORK HISTORY
R & d and Technical Director @Angiodroid
San Lazzaro Di Savena, IT
Management for the development and production of medical devices and definition of Technical Department rules- Technical Departmen leader and coordinator- Implementation of Design Control strategies with creation of matrix for the traceability between User Needs, Design Inputs, Design Outputs, Verifications and Validations in compliance with FDA 21 CFR 820.30- Application of Risk Analysis methods for electromedical devices in compliance with standard with ISO 14971- Implementations of Fault Tree Analysis (FTA)- Application of medical technical standards: IEC 60601-1, IEC 60•••12, IEC 62304 and IEC 62366- Followup on certifications related to CE, KFDA, FDA, ANVISA- Solver of technical problems related with development, production and services (remotly and on site) of medical devices.
EDUCATION
Alma Mater Studiorum – Università di Bologna
ingegneria biomedica, Ingegneria biomedica/medica
Alma Mater Studiorum – Università di Bologna
Engineer's degree, Biomedical Engineering
Medical Physics Department - S.Orsola Hospital Bologna
Internship
Birckbeck
Specilized Degree's Dissertation.
Technical Industrial Institute Blaise Pascal - Cesena
Informatic
SKILLS
ABOUT ENRICO ENRICO ALTINI ALTINI
Management for the development and production of medical devices and definition of Technical Department rules- Technical Department leader and coordinator- Implementation of Design Control strategies with creation of matrix for the traceability between User Needs, Design Inputs, Design Outputs, Verifications and Validations in compliance with FDA 21 CFR 820.30- Development of Medical Devices and creation of TECHNICAL FILES in compliance with MDR 2017/745, CE 93/42, ISO 13485 and ISO 9001- Developmemt of Medical Devices and creation of TECHNICAL FILES in compliance with FDA regulation- High knowledge about IEC 60601-1 (Electrical Safety) and IEC 60•••12 (EMC) International Standards- High knowledge of the IEC 62366 (Usability) and IEC 62304 (Software Life Cycle) International Standards-Ability to Optimize production and services costs for Medical Devices-Expert of CO2 Angiography applications.Direct experience from Operating Room (Vascular Surgery / Interventional Radiology) as Product Specialist and Analyst-Development and design of medical pneumatic circuits.Development and design of medical electronic circuits.Development and design of wireless devices (GSM,4G and WiFi).Development and design of medical architecture software.
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