The Fault Tree Analysis (FTA) is a risk management tool best used early in the product development process once you have determined the safety issues in a product, listing its Hazards (possible sources of Harm). Creating these fault trees for critical hazards early, just after a preliminary specification has been approved, can elicit potential causes of those harms. And once those potential causes of hazards leading to harm are identified, mitigations (controls) can be created and given to the design team very early. This can be done before any design has been completed to aid the designers in understanding what the risk control "architecture" should be. Like any aspect of designing a product, planning is key. With this early risk management, early competent product development planning and early product development human factors analysis can speed development, yielding an exceptional product, meeting user and patient needs, and getting a safe and effective product early to market. The attendees will learn both the Fault Tree Analysis to uncover possible causes of product and process hazards and a Mitigation Matrix to uncover potential mitigations to those causes, including risk-level estimations.