Casalecchio di Reno, Emilia-Romagna, Italy
When I am not working, I recharge in the mountains.
Completing my PhD thesis
- Management of regulatory consultancy projects - Software as a Medical Device (SaMD) technical file drafting, including - Risk Management - Clinical Evaluation - Software Life Cycle Management - Verification and Validation - Human Factors Engineering - Design History File Management - Post Market Management - Quality Management System (QMS) maintenance and improvement for SaMDs manufacturer - Notified body relationship management - Management of industrial research conduction within the context of the PhD project "Risk Based Approach to Medical AI": Risk management of AI-based medical devices, from the risks associated with the database design to the risks associated with the algorithm design and testing.
- Management of regulatory consultancy projects - Software as a Medical Device (SaMD) technical file drafting, including - Risk Management - Clinical Evaluation - Software Life Cycle Management - Verification and Validation - Human Factors Engineering - Design History File Management - Post Market Management - Quality Management System (QMS) maintenance and improvement for SaMDs manufacturer - Notified body relationship management - Management of industrial research conduction within the context of the PhD project "Risk Based Approach to Medical AI": Risk management of AI-based medical devices, from the risks associated with the database design to the risks associated with the algorithm design and testing.
Contribution to company activities: - Software development plan drafting for innovative SAMDs - Software requirement drafting for innovative SAMDs and their testing - Risk management of SAMDs
Contribution to company activities: - Usability risk assessment. - Interface design: safe-by-design medical devices. - Reporting compliance to MDR and MDD essential requirements.
Evaluation and comparison of machine learning techniques for the evaluation of blood glucose value in patients with type 1 diabetes mellitus