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).
Quality challenges in medical 3D printing The report summarizes the findings of my research into the challenges in quality management for medical companies/facilities that use 3D printing and would like to get ISO13485 certified. I would like to thank all the people who participated in this study and who completed my questionnaire!