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Learning Level: Advanced
Learning Level: Advanced
Learning Level: Expert
Learning Level: Expert
Learning Level: Foundational
Learning Level: Foundational
Learning Level: Intermediate
Learning Level: Intermediate
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RAPS Focus
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Networking Opportunity
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Ticketed Event
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Student Focus

Maddalena Pinsi, MSc

Head of Medical Devices Notified Body
BSI Notified Body
Milano, Lombardia, Italy

Maddalena is a regulatory affairs leader with extensive experience in the medical device industry and at the Notified Body BSI. She holds a Master’s Degree in Medical Biotechnology and has built a distinguished career at the intersection of science, regulation, and strategic leadership.
Throughout her career, she has successfully led the development and implementation of global regulatory strategies, translating complex requirements into clear, actionable deliverables that supported product development, compliance, and market access.
In her current leadership role as Head of the Notified Body – Medical Devices at BSI, Maddalena is responsible for the strategic and operational oversight of the Notified Body’s activities. She plays a pivotal role in shaping corporate regulatory strategy and policy, while leading the design and optimization of internal processes to ensure alignment with evolving legislative and designation requirements.
Her leadership is instrumental in upholding BSI’s reputation for excellence in regulatory compliance and conformity assessment, while driving continuous improvement across a rapidly evolving regulatory landscape.

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