Risk Analysis

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Risk analysis is a process used in the medical device industry to identify potential hazards associated with the use of a medical device and evaluate the associated risks. The goal of risk analysis is to identify any potential hazards or problems with a device and take appropriate measures to mitigate those risks. This process involves a systematic review of the device and its intended use, as well as an assessment of the potential harm that could result from its use. Risk analysis is a key component of the product development process and is typically required by regulatory authorities as part of the submission process for market approval. It is also an ongoing process throughout the device lifecycle to monitor and manage risk.