Measurements for Quality Control in Biomedical 3-D Printing: Standards, Gaps, and Missing Protocols

The integration of three-dimensional (3D) printing into point-of-care (PoC) settings enables the fabrication of patient-specific medical devices such as anatomical models, surgical guides and personalized prostheses. Additive manufacturing technologies, including Fused Deposition Modeling, Stereolithography, Selective Laser Sintering and Material Jetting, offer benefits like reduced operative time and improved patient outcomes. However, this decentralized manufacturing introduces ambiguities and regulatory uncertainties regarding design control, process validation, documentation and the requirements for safety and performance. This narrative review examines how the current regulatory vacuum constrains the safe and standardized implementation of PoC 3D printing, focusing on quality assurance (QA). It maps international regulatory and standardization frameworks relevant to decentralized production and synthesizes quantitative verification through measurement methods adopted for dimensional accuracy and mechanical performance of both rigid and soft-tissue–mimicking materials. The analysis reveals heterogeneous QA practices across institutions, with inconsistent metrics, tolerance thresholds, sampling plans and limited validation of post-processing and sterilization. Ensuring safe and reproducible PoC manufacturing, therefore, requires adapting established quality and risk-management principles into practical, auditable protocols tailored to hospital workflows. Convergence on shared metrics, acceptance criteria and sterilization-aware verification is essential to transition PoC 3D printing from local best practice to a standardized and regulated clinical manufacturing process.