Digital Traceability of Patient-Specific Photopolymer Devices: Design Input, Material Lot, Process History and Release

Patient-specific photopolymer devices require traceability across a chain in which patient data, segmentation, design transforms, build preparation, material identity, machine state, post-processing and release evidence can all change the final device. This review defines a digital thread that preserves these dependencies without assuming that a single file name, UDI or batch record is sufficient. It separates patient identity from device identity, design intent from manufacturing representation, material lot from vat history, and nominal machine settings from the executed process record. A non-compensatory release architecture is proposed in which the correct patient, approved design, qualified material, controlled process history and acceptance evidence must all reconcile before release. The framework is aligned with medical-device quality-system, risk-management, additive-manufacturing and EU traceability principles while remaining implementation-neutral.

ER-260 · Version 0.2.