Web-Based Experience Sharing Platform on Medical Device Incidents for Clinical Engineers in Hospitals.

The aim of this study was to establish a web-based platform for exchanging medical device management and maintenance experiences to enhance the professional competency of clinical engineers (CEs), which ensures the quality of medical devices and increases patients' satisfaction with medical services. Medical devices play an essential role in diagnosis and disease management. CEs are responsible for providing functional medical devices that contribute worthwhile functions to a medical service to improve patients' health and safety.

A Comparative Study of Medical Device Regulations:: US, Europe, Canada, and Taiwan.

The medical device industry is an industry dealing with multiple types of products covering a wide range of applications. As the safety and effectiveness of medical devices are vital to human health, the products must be managed by strict regulations according to the different risk levels. A total product life cycle regulatory system including product design, manufacture, premarket gate keeping, and postmarket monitoring is a common framework for medical device regulations.

A comparison study of Taiwan regulation and GHTF regulatory model on in vitro diagnostic medical devices.

In Taiwan, In Vitro Diagnostic Medical Device (IVD) is regulated as medical device since 1987, and the implementation of IVD registration was fully completed in 2005. The management system of IVD medical device is highly similar with a guidance 'The GHTF Regulatory Model' developed by Global Harmonization Task Force (GHTF) in 2011 for use of regulation development on medical devices. Area covered: In this study, the Regulatory Model developed by GHTF was compared with Taiwanese IVD management system and it has shown that these two regulatory frameworks are highly similar.

A study of medical device regulation management model in Asia.

Introduction: With the aging of the post-war baby boomer generation, the increasing demands for healthcare are driving the growth of medical industry and development of new products in order to meet the immense needs from the aging population. However, medical devices are designed to maintain the health and safety of people, therefore, medical devices are undergoing rigorous management by competent health authorities in all countries. In recent years, Asian countries have been reforming their regulations and standards for medical devices with substantial changes.

Assurance of medical device quality with quality management system: an analysis of good manufacturing practice implementation in Taiwan.

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.