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Risk Management for Existing Energy Facilities: A Global Approach to Numerical Safety Goals
Publisher: The American Society of Mechanical Engineers (ASME)
Abstract: This paper presents a structured set of numerical safety goals for risk management of existing energy facilities. The rationale behind these safety goals is based on principles of equity and ...
Review of U.S. Medical Device Regulation
Publisher: The American Society of Mechanical Engineers (ASME)
Abstract: Medical device regulation plays a significant role in the design, development, and commercialization of new medical technologies. A comprehensive understanding of the various regulatory requirements ...
Stage-Gate Process for the Development of Medical Devices
Publisher: The American Society of Mechanical Engineers (ASME)
Abstract: The medical device development process has become increasingly complex in recent years. The advent of new technology concepts, stricter regulatory requirements, and the ever increasing importance ...