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Name
Selene Malvicino
Title
Lead Audit QMS - Bureau Veritas Group
Bio
Master's Degree in Bioengineering, Neuroengineering and Bio-ICT in December 2018, Università di Genova
Postgraduate vocational training courses, Polymeric materials and products for the biomedical sector in January 2021, Università di Bologna
I worked from 2019 to 2023 at OT Bioelettronica srl within regulatory affair department. Especially, I was responsible for Verification and Validation of active MD (electromyographs, dynamometers, ergometers and devices for the evaluation of bruxism, including integrated software), with a focus on research and development of flexible electromyography electrodes and electrodes for electroencephalography, as well as of devices for the study of joint movement.
In 2023 I worked for Adiramef Spa at the Vercelli healthcare facility where I held the role of PROJECT MANAGER focusing on verification and validation of active MD Management and coordination of installation, preventive and corrective maintenance of electromedical equipment.
I have been working in Bureau Veritas Italia since September 2023 as a Product Reviewer according to MDR, Lead Auditor (MDd, MDR, ISO 9001, ISO 13485) and as coordinator of the internal clinicians in charge for the evaluation of pre-market and post-market clinical evidence
Postgraduate vocational training courses, Polymeric materials and products for the biomedical sector in January 2021, Università di Bologna
I worked from 2019 to 2023 at OT Bioelettronica srl within regulatory affair department. Especially, I was responsible for Verification and Validation of active MD (electromyographs, dynamometers, ergometers and devices for the evaluation of bruxism, including integrated software), with a focus on research and development of flexible electromyography electrodes and electrodes for electroencephalography, as well as of devices for the study of joint movement.
In 2023 I worked for Adiramef Spa at the Vercelli healthcare facility where I held the role of PROJECT MANAGER focusing on verification and validation of active MD Management and coordination of installation, preventive and corrective maintenance of electromedical equipment.
I have been working in Bureau Veritas Italia since September 2023 as a Product Reviewer according to MDR, Lead Auditor (MDd, MDR, ISO 9001, ISO 13485) and as coordinator of the internal clinicians in charge for the evaluation of pre-market and post-market clinical evidence
