About the Speaker
Rossella is a PhD-level biomedical engineer with over 13 years of experience in the Medical Device Industry as R&D engineer, V&V system engineer, Project manager, and Q/RA manager. At Veranex, Rossella supports you during the design and development of active medical devices including active implantable medical devices, wearable devices and active hand-held instruments. She provides support with regulatory pathway assessment, EN ISO 13485 internal audit leading, electrical safety and risk management activities in accordance with IEC 60601 and ISO 14971, with verification and validation activities, and with the preparation of the technical documentation, according to the applicable regulatory requirements for submissions in the EU and in the US.
By attending this training you will:
The training is aimed at engineers, product managers, regulatory affairs specialists, or regulatory managers seeking to enhance their competence in this rapidly developing domain.
EUR 350 including course material and certificate