Pieter Smits

Project Manager | Project Governance Lead | SaMD Expert | Industrial Engineer

Pieter Smits is a trusted expert in Software as a Medical Device (SaMD), cybersecurity, and AI regulation, helping companies bridge the gap between innovation and compliance. At QbD Group, he leads complex SaMD projects while shaping project governance frameworks that meet international standards.

Biography

Pieter Smits is an experienced project manager and regulatory consultant, specialized in medical device software and AI-related compliance. With a background as an industrial engineer, Pieter has built strong expertise in SaMD development, project governance, and emerging digital health regulations.

As a Project Governance Lead at QbD Group, he plays a central role in guiding clients through the fast-evolving regulatory landscape, including cybersecurity frameworks, AI legislation, and software lifecycle validation under MDR and IVDR.

Pieter is an active contributor to QbD’s thought leadership content and frequently speaks at industry events such as TOPRA, where he shares insights on SaMD and AI/ML regulatory strategies.

He is a member of ISPE and regularly engages in discussions around the future of AI in medical devices. Beyond his consulting work, Pieter is passionate about sports, reading, and programming — always looking to explore the intersection of technology and human health.