Designing a medical device involves several critical steps to ensure safety, efficacy, and regulatory compliance. What are the key stages in the medical device design process, including initial concept development, prototyping, and testing? How do designers incorporate user needs, clinical requirements, and ergonomic considerations into the design of medical devices? What role do regulatory guidelines, such as ISO 13485 and FDA regulations, play in shaping the design and development process? Additionally, how is risk management integrated into medical device design to identify and mitigate potential hazards throughout the product lifecycle?
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