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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. However, the variety and innovativeness of medical devices are challenging the current regulatory frameworks. Hence, the competent authorities responsible for medical devices worldwide keep renewing their regulatory systems to ensure the safety and effectiveness of medical devices. This review aims to provide an informative review of the regulatory frameworks of medical devices in the United States, Europe, Canada, and Taiwan, with a particular focus on updated regulatory changes in these countries and the current status of global harmonization on medical devices.

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Abstract. We propose a new approach towards Particle Swarm Optimization named Agent-based PSO. The swarm is elevated to the status of a multi-agent system by giving the particles more autonomy, an asynchronous execution, and superior learning capabilities. The problem space is modeled as an environment which forms clusters ofpoints that are known to be non-optimal and this transforms the environment into a more dynamic and informative resource.

The purpose of this paper is to introduce an innovative framework for implementation of ambient intelligence (AmI) environments. Compared to the existing state-of-the-art approaches, this framework creates a more decentralized and distributed AmI environment. In addition, the proposed approach is not limited to one specific domain, unlike many others. The openness of the presented architecture allows it to support a variety of devices ranged from small-embedded sensors to complex computing facilities. Finally, given that this approach is formulated based on multi-agent standard concepts, it can be easily implemented as add-on for existing software agent platforms to achieve rapid deployment. Implications for the development of this framework and future directions are discussed.