Assurance of Medical Device Quality with Quality Management System: An Analysis of Good Manufacturing Practice Implementation in Taiwan
Joint Authors
Li, Tzu-Wei
Tu, Pei-Weng
Liu, Li-Ling
Wu, Shiow-Ing
Source
Issue
Vol. 2015, Issue 2015 (31 Dec. 2015), pp.1-7, 7 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2015-05-17
Country of Publication
Egypt
No. of Pages
7
Main Subjects
Abstract EN
The implementation of an effective quality management system has always been considered a principal method for a manufacturer to maintain and improve its product and service quality.
Globally many regulatory authorities incorporate quality management system as one of the mandatory requirements for the regulatory control of high-risk medical devices.
The present study aims to analyze the GMP enforcement experience in Taiwan between 1998 and 2013.
It describes the regulatory implementation of medical device GMP requirement and initiatives taken to assist small and medium-sized enterprises in compliance with the regulatory requirement.
Based on statistical data collected by the competent authority and industry research institutes, the present paper reports the growth of Taiwan local medical device industry after the enforcement of GMP regulation.
Transition in the production, technologies, and number of employees of Taiwan medical device industry between 1998 and 2013 provides the competent authorities around the world with an empirical foundation for further policy development.
American Psychological Association (APA)
Li, Tzu-Wei& Tu, Pei-Weng& Liu, Li-Ling& Wu, Shiow-Ing. 2015. Assurance of Medical Device Quality with Quality Management System: An Analysis of Good Manufacturing Practice Implementation in Taiwan. BioMed Research International،Vol. 2015, no. 2015, pp.1-7.
https://search.emarefa.net/detail/BIM-1056325
Modern Language Association (MLA)
Li, Tzu-Wei…[et al.]. Assurance of Medical Device Quality with Quality Management System: An Analysis of Good Manufacturing Practice Implementation in Taiwan. BioMed Research International No. 2015 (2015), pp.1-7.
https://search.emarefa.net/detail/BIM-1056325
American Medical Association (AMA)
Li, Tzu-Wei& Tu, Pei-Weng& Liu, Li-Ling& Wu, Shiow-Ing. Assurance of Medical Device Quality with Quality Management System: An Analysis of Good Manufacturing Practice Implementation in Taiwan. BioMed Research International. 2015. Vol. 2015, no. 2015, pp.1-7.
https://search.emarefa.net/detail/BIM-1056325
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1056325