Risk must always be handled in a proper manner when working with Medical Devices. ISO 14971:2019 is an internationally harmonized standard, stating how to reduce risks, increase patient safety and ensure that you as a manufacturer can bring your medical devices to the market in a safe and efficient way.
Whether you are a medical device professional, or a beginner, you are responsible for your device’s properties and performance in relation to patient safety. As a result, it is essential that you understand risk management and how to work with it.