Walk me through your process for performing a risk analysis (e.g., FMEA, FTA) on a new biomedical system design, including how you identify potential hazards, estimate their severity and probability, and implement mitigation strategies to meet safety requirements and regulatory expectations.

I apply a structured FMEA (Failure Mode and Effects Analysis) and FTA (Fault Tree Analysis) process. First, I define the system boundaries and intended use. Then, I systematically identify potential failure modes for each component or function, brainstorming hazards (e.g., electrical, mechanical, biological) using historical data and regulatory guidance (e.g., ISO 14971). Severity is ranked (1-5) based on potential patient harm, and probability (1-5) considers design complexity and component reliability. The Risk Priority Number (RPN) is calculated (Severity x Probability). For high RPNs, I develop mitigation strategies (e.g., redundant systems, design changes, warnings) and re-evaluate the RPN. This iterative process ensures risks are reduced to an 'as low as reasonably practicable' (ALARP) level, documented in a risk management file, and verified through testing to meet regulatory expectations.

My process for performing a risk analysis on a new biomedical system design, such as a drug delivery pump, integrates FMEA and FTA, guided by ISO 14971. I begin by defining the system's intended use, user profile, and operating environment. Next, I systematically identify potential hazards by dissecting the system into subsystems and components, brainstorming failure modes (e.g., software malfunction, material degradation, user error) through cross-functional team meetings and reviewing similar device recalls. Severity is assessed based on potential patient harm (e.g., minor injury, permanent disability, death), and probability considers component reliability data, design complexity, and manufacturing process controls. I calculate the Risk Priority Number (RPN) for each identified risk. For unacceptable RPNs, I implement mitigation strategies following the hierarchy of controls: inherently safe design, protective measures, and information for safety. This includes design changes (e.g., redundant sensors), alarm systems, and comprehensive user training. The residual risk is then re-evaluated, and all activities are meticulously documented in a risk management file, which is a living document, continuously updated throughout the product lifecycle to ensure ongoing compliance with regulatory expectations like FDA 21 CFR Part 820.