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Guide to field safety corrective actions for medical devices and in-vitro diagnostic medical devices

机译：医疗设备和体外诊断医疗设备现场安全纠正措施指南

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Irish Medicines Board (IMB);
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年度 2010
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1. Advisory opinion of the AWMF Ad hoc Commission In-vitro Diagnostic Medical Devices regarding in-vitro diagnostic medical devices manufactured and used only within health institutions established in the Union according to Regulation (EU) 2017/746 (IVDR) [J] . Petra Hoffmüller, Monika Brüggemann, Thomas Eggermann, German Medical Science . 2021,第a期

机译：AWMF AD HOC委员会在体外诊断医疗器械上制造和仅根据监管（欧盟）2017/746（IVDR）在联盟建立的卫生机构内使用的体外诊断医疗器械的咨询意见
2. Analysis of regulatory requirements of medical devices and in-vitro diagnostics worldwide for the development of an efficient procedure of registration for manufacturers of medical products : Current Directions in Biomedical Engineering [J] . Magdalena Kedwani, J?rg Schr?ttner, Christian Baumgartner Current Directions in Biomedical Engineering . 2019,第1期

机译：为开发医疗产品制造商的有效注册程序而对全球医疗设备和体外诊断的法规要求进行分析：生物医学工程的当前方向
3. Encouraging Research and Development of Pediatric Medical Devices Through Legislative and Regulatory Action: The Pediatric Medical Device Safety and Improvement Act of 2007 in Context [J] . ESTHER W.B. BLEICHER Food and Drug Law Journal . 2009,第3期

机译：通过立法和监管行动来鼓励儿科医疗器械的研究与开发：背景下的2007年儿科医疗器械安全与改进法案
4. Design of Portable Microfluidic Cytometry Devices for Rapid Medical Diagnostics in the Field [C] . James F. Leary Imaging, Manipulation, and Analysis of Biomolecules, Cells, and Tissues XVII . 2019

机译：用于现场快速医学诊断的便携式微流式细胞仪的设计
5. An exploratory case study of the professional teaching and learning practices of surgeons providing instruction in the medical devices and diagnostics industry: Implications for faculty development and endorsement by the professional field. [D] . Kenahan, Rita Anne. 2014

机译：在医疗设备和诊断行业提供指导的外科医生的专业教学实践的探索性案例研究：对专业领域教师发展和认可的启示。
6. Advisory opinion of the AWMF Ad hoc Commission In-vitro Diagnostic Medical Devices regarding in-vitro diagnostic medical devices manufactured and used only within health institutions established in the Union according to Regulation (EU) 2017/746 (IVDR) [O] . Petra Hoffmüller, Monika Brüggemann, Thomas Eggermann, 2021

机译：AWMF临时委员会在体外诊断医疗器械的咨询意见这些医疗器械均仅在工会中建立的卫生机构内根据条例（欧盟）2017/746（IVDR）
7. Analysis of regulatory requirements of medical devices and in-vitro diagnostics worldwide for the development of an efficient procedure of registration for manufacturers of medical products [O] . Magdalena Kedwani, Jörg Schröttner, Christian Baumgartner 2019

机译：在全球医疗设备和体外诊断的监管要求分析，为医疗产品制造商进行高效注册程序的开发
8. Baseline Data on the Availability of Medical Devices and In-Vitro Diagnostic Products [R] . 1980

机译：医疗器械和体外诊断产品可用性的基线数据

Guide to field safety corrective actions for medical devices and in-vitro diagnostic medical devices

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