The document describes risk management as a four-tiered process to: Your risk management bible and explainer is ISO 14971:2019 Medical Devices - Application of risk management to medical devices. It’s your risk management team’s job (more on selecting your team below) to minimize risks as much as possible, and to justify remaining risks. There’s inherent risk in using any medical device.

Here are the first steps to conducting a risk assessment for your medical device. But actually understanding the risk management process proves difficult. You probably already know that risk management is extremely important. If your product is consistently causing problems, the FDA might force you to issue a costly recall. Moreover, risk management doesn’t stop being a concern once your product is on the market. In fact, the FDA keeps a complaint database. Then, you’ll lose valuable time and money going back to address any oversights. You need to account for and mitigate the risks associated with your product early on, so it’s safe for users and passes increasingly stringent FDA requirements.Īnd what happens if you don’t properly account for risk in the early stages of product development? The FDA might send you a letter requesting additional information in response to your submission for approval. Risk management is a crucial aspect of medical device development.