Medical device design necessitates an assessment of risk. The need is prudent given their ecosystem of use, but also mandated by regulatory agencies. Risk management uses analysis protocols to identify and predict situations where a device may fail and assess the consequences. Common techniques, like Failure Mode and Effects Analysis (FMEA) must expand to go beyond engineering and material failure to identify hazard risks due to user-device interactions or "use errors."
During this webinar, we will discuss the practice of the FMEA with added upgrades, such as a Task Analysis and how integration with simulated use labs can help you and your design team be more successful at reducing patient risk.