The Project Management Office as a Governance Engine for Medical-Device Quality Management Systems in Public Hospitals: A Conceptual Framework Aligned with Saudi Vision 2030

National healthcare transformation programmes increasingly depend on the disciplined execution of complex, interdependent projects. Within this context, the Project Management Office (PMO) has evolved from an administrative reporting unit into a strategic governance entity. This perspective paper argues that the PMO is uniquely positioned to serve as the governance engine for medical-device quality management systems (QMS) in public hospitals, and that this role is both underexamined in the literature and highly consequential for patient safety, regulatory compliance, and national transformation agendas such as Saudi Vision 2030. Drawing on established project- and quality-governance frameworks and the international medical-device QMS standard ISO 13485:2016, the paper develops a conceptual model linking PMO maturity to medical-device governance outcomes. It then proposes how emerging artificial-intelligence (AI) capabilities can be integrated into the QMS to support risk surveillance, document control, and continuous improvement without displacing accountability. The framework is offered as a foundation for empirical validation and as a practical reference for hospital leaders operating in rapidly transforming health systems. The views expressed are those of the author and do not represent the official position of any institution.