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Maddalena Pinsi
Regulatory Manager, Regulatory Services - Notified Body at BSI


Maddalena holds a Master Degree in Medical Biotechnology and has more than 10 years’ experience in regulatory affairs within the medical device industry. During her industry career, she developed and executed global regulatory strategies to secure regulatory approvals on a global scale, translating regulatory requirements into project/product requirements.

In her current role in BSI, she develops policies and processes for the Medical Devices team to ensure compliance with EU regulatory requirements.

Agenda Sessions

  • EU Medical Device Regulation, Notified Body Overview and Update from BSI