The benefits that 3D technologies bring to cranio-maxillo-facial (CMF) surgery have led to their implementation in in-hospital units aiming to support diagnostic and treatment processes. This integration has enabled healthcare institutions to evolve from users to manufacturers of personalised medical devices, fostering accurate and safer surgeries, improving operational efficiency, and contributing to the sustainability of the healthcare system. This chapter explores the applicable regulations, normative requirements, and operational models to be considered when implementing a 3D Point-of-Care lab (from now on, 3DPOC) on a global scale. Furthermore, it addresses key factors involved in implementing a quality management system (QMS) to ensure the efficacy and safety of medical devices developed within the hospital itself. An appropriate QMS will help the 3DPOC to meet the infrastructure, resources, and standardised operational procedures typical of a medical device manufacturer.