A study on Certification System of Medical Device

• Main Authors: Chin-fu Chen, 陳進富
• Other Authors: js-Lin
• Format: Others
• Language: zh-TW
• Published: 2007
• Online Access: http://ndltd.ncl.edu.tw/handle/77750893445336418781

碩士 === 義守大學 === 管理研究所碩士班 === 95 === After the national health insurance put into practice, medical payment, government’s policy and enactment regarding health insurance are changed. It has influenced the medical structure, management and development of the medical device manufacturers. For example, all medical device manufacturers are required by Department of Health, Executive Yuan to gain the certification from GMP (Good Manufacturing Practices) due on June 20, 2005. In addition, foreign products need to apply for QSD (Quality System Documentation) from Department of Health. Without the certification of GMP and QSD, the foreign product is not allowed to sell the products in Taiwan. It is a manificated change for medical device manufacturers. This study, based on the concept of complex theory, applys the agent-based models incorporating the object orientation methodology, to investigate the relationship among the quality, behavior, and object of each agent. In this framework, agents interact with each other and the environement with policy changes. As a result, agent evolves and adapts in order to survive in the environement. The influence is related to behavior evolution between agents and the industry. The manufacturers can revise their behaviour and therefore reinforce and self-adjust from time to time. This study offers a new approach and insight into the medical device industry.