Case Management in Patient-Specific Surgical Planning, Surgical Guides, and Custom-Made Implants Case management plays a vital role in the production and implementation of 3D-printed patient-specific surgical planning, surgical guides, and custom-made implants. Not only does it ensure streamlined operations, but it also helps achieve traceability—a fundamental requirement of a Quality Management System (QMS) under ISO …
Tag: personalized
Guidance PMD
Personalized Medical Devices – Regulatory Pathways Last week, the IMDRF released the second edition (2023) of document IMDRF/PMD WG/N58. The previous edition dated from 2020. In this latest version, they elaborate a bit more on the concept of the Medical Device Production System (MDPS).