Medical device software risk management is critical to protect patients and ensure the safety of medical devices. At Wi4 Corporation, we have extensive experience in helping companies manage the risks associated with medical device software. We understand the complex regulatory environment and have the expertise to help you develop a comprehensive risk management program that meets FDA requirements.

Our approach includes a risk assessment of your software development process, identification of potential hazards, and development of mitigation strategies. We also provide training for your team on how to identify and manage risks throughout the software development lifecycle. With our help, you can be confident that your medical device software is safe and reliable.