The key to risk management in medical device design is to identify and assess risks as early in the design and development process as possible. This can be done at the concept level early for new technologies, or at the detailed design level later for existing items or evolved concepts. It also should close the loop with clinical and field experiences to meet the desires of the new Medical Device Regulation (MDR) in Europe. The value from Risk Management comes from better project execution, not just documenting the situation. Learn how to best insert risk management assessment into each stage of the design and manufacturing process to best mitigate risk and improve profitability. Best practices require more than simply complying to the standards.