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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. [ABSTRACT FROM AUTHOR]

The purpose of this study was to survey occupational therapists for the usage problems and for their improvement needs for upper extremity rehabilitation equipment (UERE). A questionnaire was given to experienced occupational therapists from 113 hospitals that provide occupational therapy services with three or more professional full-time therapists. A total of 48 hospitals sent back questionnaires, and 184 valid questionnaires were received. Most of the UERE had two major problems: The base of the equipment was unstable, and the equipment was uninteresting to use. The therapists reported that three major needs for design improvement in the UERE were adjustability of functions, exchangeability of components and recording of movement data. Some therapists had suggestions for designing new types of UERE, such as manual dexterity training equipment, activities of daily living oriented equipment, sensory re-education equipment, arm supination and pronation training equipment, and wrist extension training equipment. These findings reveal the genuine user needs of upper extremity devices and provide useful applications to the development and re-design of these devices. However, obtaining opinions primarily from experienced occupational therapists may pose a methodological limitation of this study. In future research, it is advised to include patients' opinions and also investigate whether a clinician's years of experience would affect his or her viewpoint of usage problems and improvement needs of the UERE. Copyright © 2013 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]