QbD Group
Pieter Smits is a seasoned professional with extensive expertise in project management and medical device software. Currently serving as a Project Governance Lead at QbD since August 2013, Pieter develops and implements project management methodologies aligned with corporate strategies. As a Software as a Medical Device and Medical Device Software Expert, Pieter is well-versed in EU and US regulations, focusing on AI and cybersecurity requirements. Pieter also holds a certification as a Lead Auditor for ISO13485, conducting audits for regulatory compliance in the medical device sector. Prior experience at Pfizer included roles as Project Lead for business intelligence implementation and Project Engineer, where Pieter contributed to the development and compliance of electronic batch records. Pieter holds a Master of Science degree in Bioscience Engineering with a specialization in cell and gene technology from KU Leuven.