This is a guide for medical device professionals looking to gain a deeper understanding of the risk management process and how it may be applied. A fully implemented and well-designed risk management system can help your company not only comply with ISO 14971, but also improve outcomes throughout the product lifecycle.
Benjamin Franklin famously said “an ounce of prevention is worth a pound of cure” and it’s true. Identifying and mitigating issues early in the process is beneficial and may prevent costly design changes, production delays, and potential recalls later on. Following this logic, the same messaging that helps to build a culture of quality can help you to build a culture that embraces risk management.