You need to enact your risk management plan early in development so you’re not scrambling to get your FDA submission across the finish line and missing potential safety concerns. This is where you’ll dive deep, considering every possible risk associated with that particular product. This company-wide plan should apply to every product you develop.Īdditionally, you’ll need to produce a risk management plan specific to each medical device. Your organization should have a standard operating procedure addressing your risk management process. The first step to successful risk management begins before analyzing your actual device. In simpler terms, ISO 14971:2019 is a guide you can use to develop and maintain your own risk management process. The entirety of the process is then laid out in the ISO standard, which ultimately “…provides the framework within which experience, insight, and judgement are applied systematically to manage the risks associated with the use of medical devices.” Monitor the effectiveness of these controls.Identify the hazards associated with a medical device,Įstimate and evaluate the associated risks, 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.

Medical device risk management template