As a manufacturer of Class 1 medical devices, you are required to conduct a risk assessment and establish a quality management system (QMS) before submitting your device for FDA approval. The risk assessment should identify potential hazards associated with your device and determine the likelihood and severity of harm that could result from those hazards. The QMS should outline your company's procedures for ensuring the safety and effectiveness of your device throughout its lifecycle. It's important to establish these systems early in the development process to ensure that your device meets FDA requirements and to avoid costly delays in the approval process.