Open Forum: Use Related Risk Analysis Q&A

Conducting a use related risk analysis (URRA) is one of the most important steps when applying a human factors engineering (HFE) process during development of your medical device or combination product. This is understandable noting your goal is to develop a product that is safe and effective to use. Your risk analysis will be key in determining if you achieve this objective. Whether it’s helping determine user interface requirements, the scope of your HF validation efforts, or whether the device has acceptable residual risk, the URRA is the foundation for your most critical HFE activities. Given its importance, it’s no wonder there are often questions amongst teams when it comes to performing this key activity. Let us help you with some of those questions.