3D technology has found it’s way to the hospital and is significantly improving patient care. In the article below I highlight the opportunities and identify the risks of 3D printing in a hospital setting. It talks about regulatory and quality management aspects and links to helpful guidance documents.
Tag: MDPS
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).