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).
Author: Dr Boolean
Research Report
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!