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Quality Assurance in Medical Devices: A Bibliometric Analysis

Quality Assurance in Medical Devices: A Bibliometric Analysis

Juliana Shaibun
Copyright: © 2021 |Pages: 13
ISBN13: 9781799847724|ISBN10: 1799847721|EISBN13: 9781799847731
DOI: 10.4018/978-1-7998-4772-4.ch019
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MLA

Shaibun, Juliana. "Quality Assurance in Medical Devices: A Bibliometric Analysis." Handbook of Research on Technology Applications for Effective Customer Engagement, edited by Norazah Mohd Suki, IGI Global, 2021, pp. 302-314. https://doi.org/10.4018/978-1-7998-4772-4.ch019

APA

Shaibun, J. (2021). Quality Assurance in Medical Devices: A Bibliometric Analysis. In N. Mohd Suki (Ed.), Handbook of Research on Technology Applications for Effective Customer Engagement (pp. 302-314). IGI Global. https://doi.org/10.4018/978-1-7998-4772-4.ch019

Chicago

Shaibun, Juliana. "Quality Assurance in Medical Devices: A Bibliometric Analysis." In Handbook of Research on Technology Applications for Effective Customer Engagement, edited by Norazah Mohd Suki, 302-314. Hershey, PA: IGI Global, 2021. https://doi.org/10.4018/978-1-7998-4772-4.ch019

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Abstract

Quality management system (QMS) is acknowledged as the primary method for any manufacturer, especially medical device manufacturers, in order to sustain the product quality in the competitive advantage in business environment. QMS is an essential requirement for regulatory control in high risk medical devices. Globally, the number of medical device manufacturers certified by ISO 13485 is escalating. Ownership of this certification symbolizes the medical device manufacturer acquired high performance in their QMS. This bibliometric provides a brief review of the quality assurance and how safety plays an important role in medical devices. Bibliometric analysis guided user to summarize the essential part of quality assurance process in medical device. The insights presented in this research assist in building a firm theoretical base and direction for future research.

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