【序号】:1 【作者】:Johann Harer 【题名】:Manufacturing and Quality Assurance in Compliance with the MDR and IVDR 【期刊】:Medical Devices and In Vitro Diagnostics 【年、卷、期、起止页码】:pp 505–542 【全文链接】:https://link.springer.com/referenceworkentry/10.1007/978-3-031-22091-3_20