Archives: Speakers

Carmen Bellebna is a seasoned professional in the medical device and healthcare technology sector, with a diverse background spanning biotechnology, quality management, and regulatory affairs. She holds multiple advanced degrees, including a Master’s in Health and Medical Management, and diplomas in Biotechnology and Industrial Engineering.

Currently, Carmen serves as the Director of Quality & Regulatory Affairs at Deepeye Medical GmbH, where she spearheads the CE marking process for AI-powered medical device software. Her focus is on Software as a Medical Device (SaMD) in the ophthalmology sector, specifically working on treatment planning systems for neovascular Age-related Macular Degeneration (nAMD). Her expertise in implementing quality management systems compliant with MDR 2017/745 and EN ISO 13485 ensures cutting-edge medical software meets rigorous regulatory standards.

With over two decades of experience, Carmen has held key positions at notable organizations such as TÜV SÜD PS GmbH, where she worked as a Lead Auditor for medical devices. Her proficiency extends to auditing quality management systems, assessing technical documentation, and evaluating sterilization processes across various medical device categories.

Wafaa Hassan, MSc, is a Senior Pharma Analyst in the Digital team at GlobalData’s London office. Her responsibilities involve writing reports and providing insights on digital strategy across disease areas and channels. Prior to working in the digital team, Wafaa worked in the thematic research team at GlobalData, where she contributed to quantitative and qualitative analysis reports on disruptive themes and technologies, with a focus on Pharma, Healthcare and Medical Devices sectors. Prior to joining GlobalData, Wafaa studied for an MSc in Healthcare Management at City, University of London.