When answering this question, emphasize your understanding of the critical importance of safety and risk management in biomedical engineering. Discuss specific methodologies and frameworks you use, such as Failure Mode and Effects Analysis (FMEA), Hazard Analysis and Critical Control Points (HACCP), or ISO 14971 for risk management in medical devices. Provide examples from past projects where you successfully identified and mitigated risks, ensuring compliance with regulatory standards. Highlight your proactive approach to safety, continuous monitoring, and improvement processes to ensure the highest standards of patient safety and device reliability.
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