Alessandro Maula Email & Phone Number

Auckland, New Zealand

Como, Italy

Development of class Ir and IIa reusable and disposable surgical instruments for ophthalmology. Reporting directly to management, I am responsible for design activities, ensuring regulatory requirements and company quality. In particular, the main duties as R&D and Regulatory manager are:• Design planning which involves coding the project and scheduling design activities such as the definition of requirements, risk analysis, issuing drawings and other output elements, review, verification… Show more Development of class Ir and IIa reusable and disposable surgical instruments for ophthalmology. Reporting directly to management, I am responsible for design activities, ensuring regulatory requirements and company quality. In particular, the main duties as R&D and Regulatory manager are:• Design planning which involves coding the project and scheduling design activities such as the definition of requirements, risk analysis, issuing drawings and other output elements, review, verification and validation of the design, transfer to production;• The drafting of the technical documentation that will make up the technical file in compliance with European regulations.• Coordination of PMS and PMCF activities, analysis of the data collected and drafting of the related reports.• Scouting for new suppliers and new manufacturing technologies to develop innovative devices• Preparation of documentation for registration and maintenance of registration in European and non-European markets.• Communication and interaction with the notified body for the management of changes to the technical files and in general to manage the CE surveillance and certification activities.• Participation in international conferences as a reference for R&D activities and as technical support to the commercial department.The activities I carry out related to the role of company quality manager are:• Maintenance and constant improvement of the quality management system.• Communication with notified bodies and competent authorities to fulfil the supervision and surveillance requirements of the quality management system by ISO 13485.• Communication with management to update the progress of company objectives, discuss risks and opportunities, and management review.• Internal audits on processes conducted by other company figures.• External audits on suppliers• Management of complaints, non-conformities and corrective actions. Show less

Vuokatti, Northern Finland, Finland

In cross-country (XC) skiing, double poling (DP) is a widely used skiing technique in which skiers push synchronously two poles to generate propulsion. Cycle parameters as cycle time, push and recovery time, cycle speed, and cycle length play an important role in performance assessment. The use of inertial measurement units (IMUs) to assess cycle parameters have the advantages to require simple setup and to allow measuring skiing kinematics continuously outside. The aim of the thesis was to… Show more In cross-country (XC) skiing, double poling (DP) is a widely used skiing technique in which skiers push synchronously two poles to generate propulsion. Cycle parameters as cycle time, push and recovery time, cycle speed, and cycle length play an important role in performance assessment. The use of inertial measurement units (IMUs) to assess cycle parameters have the advantages to require simple setup and to allow measuring skiing kinematics continuously outside. The aim of the thesis was to identify cycle events (pole hits and lifts) and to calculate cycle parameters by linear acceleration and angular velocity signals collected using IMUs fixed on the skiers and to assess errors (accuracy and precision) of the results in comparison with a gold standard system.Main tasks and responsibilities:• Design and execution of experimental protocols to find solutions to specific biomechanical problems.• Development of effective and organized Matlab codes to process signals acquired with accelerometers and gyroscopes.• Wrote daily reports and prepared data presentations.• Detailed literature research about the use of IMUs sensors in movement analysis.• Communicated with experts from different scientific fields. Show less

Master'S Degree, Biomedical/Medical Engineering, 107/110

Bachelor'S Degree, Biomedical/Medical Engineering, 100/110

Education record