BSI ın biyouyumluluk konusunda üreticilerden beklediği konular hakkında İngilizce sunuş yapılacaktır.
Ajanda
Sunuş: Piero Trabucco,
Principal Technical Specialist and Scheme Manager Vascular Devices
Biocompatibility Strategy, Biocompatibility Test Selection, Chemical Characterization
Principal Technical Assessor and CE Certification Scheme Manager at BSI, a leading EU Notified Body providing conformity assessment under the European Directives and the MDR/IVDR Regulations. He holds a master’s degree in Industrial Biotechnology and a PhD in Biomolecular Sciences, and brings over 18 years of experience in R&D and Regulatory Affairs within the Life Sciences industry – including both pharmaceutical and med-tech companies.
Piero’s expertise focuses on the biological evaluation and chemical characterization of medical devices. He is a member of ISO/TC 194, the international technical committee responsible for the ISO 10993 series on biological and clinical evaluation of medical devices. He also actively contributes to the Notified Body expert group on biological safety and biological equivalence under the MDR.
