Removing the fuzziness in medical device manufacturing R&D

Cheng Ling Tan; Yann Mey Yee; Aizzat Mohd Nasurdin; Sook Fern Yeo

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Removing the fuzziness in medical device manufacturing R&D

机译：消除医疗器械制造研发中的模糊性

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Ensuring regulatory compliance plays a significant part in the cost of research and development (R&D) in any sector where the work is inherently unstructured, or fuzzy. This includes aircraft manufacturing, pharmaceuticals, and the medical device industry, which produces instruments for use in medical procedures. A study of a medical device manufacturer gives insight into the problem of fuzziness in the R&D phase and shows how interconnecting the different functions of the business can contain costs. Doing so entails nurturing strong supplier-customer relationships, sharing knowledge, and fostering a fulfillment-oriented organizational culture that values lifelong learning.

机译：在任何工作本质上是非结构化或模糊的部门中，确保合规性在研发（R＆D）成本中起着重要作用。这包括飞机制造，制药和医疗器械行业，这些行业生产用于医疗程序的仪器。对医疗设备制造商的一项研究可以洞悉研发阶段的模糊性问题，并展示如何将业务的不同职能相互联系可以控制成本。这样做需要培养牢固的供应商-客户关系，分享知识，并培养重视成就感的终身学习型组织文化。

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来源
《Global business and organizational excellence》 |2019年第1期|29-36|共8页
作者
Cheng Ling Tan; Yann Mey Yee; Aizzat Mohd Nasurdin; Sook Fern Yeo;
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作者单位

Universiti Sains Malaysia (USM);

School of Management Universiti Sains Malaysia;

Faculty of Business Multimedia University Melaka Malaysia;

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正文语种 eng
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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. Development and Manufacture of Medical Devices at the Avionika Scientific-Manufacturing Association [J] . A. A. KrasiPnikov Biomedical engineering . 2004,第4期

机译：Avionika科学与制造协会开发和制造医疗器械
3. First amendment to the international standard for EMC on medical devices: Amendment 1 to IEC 60601-1-2 is worth a careful reading by anyone involved in the design, manufacturing, and/or testing of electrical medical equipment [J] . DANIEL D. HOOLIHAN Interference Technology: EMC Directory & Design Guide . 2005,第2005期

机译：医疗设备EMC国际标准的首次修订：涉及电气医疗设备设计，制造和/或测试的任何人都应认真阅读IEC 60601-1-2的修订1
4. EVALUATION OF MEDICAL DEVICES USING FUZZY TOPSIS WITH TYPE-2 FUZZY NUMBERS [C] . ISMAIL BURAK PARLAK, A.CAGRI TOLGA Decision making and soft computing . 2014

机译：利用带有2型模糊数的模糊顶点对医疗设备进行评估
5. Development and Optimization of High-Resolution Additive Manufacturing towards Implantable Biomedical Devices [D] . Ware, Henry Oliver Tenadooah. 2020

机译：高分辨率添加剂制造对可植入生物医学装置的开发与优化
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. MODERN MEDICAL DEVICES AND HOSPITAL DECISIONMAKING: A REVIEW OF ETHICAL AND SOCIAL CONSIDERATIONS DURING THE MANUFACTURE AND THE USE OF ADVANCED MEDICAL DEVICES [O] . Shudipta Choudhury 2019

机译：现代医疗器械和医院决策：在制造过程中的道德和社会考虑因素和使用先进的医疗设备

Removing the fuzziness in medical device manufacturing R&D

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