Regulatory Lead
BSI
Daniela is a Regulatory Lead within the BSI's AI Notified Body. She is responsible for regulatory strategy, policies, procedures and accreditation/designation as a Conformity Assessment Body and Notified Body. Her main role is to establish and maintain compliance to regulatory requirements in terms of organizational, quality management processes and resources, supporting Operations in the certification activities and training program.
Daniela joined BSI in 2017 as Technical Specialist, Scheme Manager and Clinical Team Lead in the Active Medical Devices Team. She currently holds a Bachelors and Masters in Biomedical Engineering, a Masters in Health Technology Assessment and has over 17 years’ experience in medical devices, including AI software, having worked in technology development, technology transfer, patents, testing, clinical studies, and as a medical device lead auditor/national expert for the Italian Ministry of Health in the European Commission working groups and Joint Assessments. She is a former IEEE member actively participating to the CEN-CENELEC Joint Technical Committee 21 on Artificial Intelligence.
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