Substantial equivalence argument builder
The Substantial Equivalence Argument Builder simplifies the creation of robust arguments for your device submissions. This innovative tool guides you through the process of demonstrating substantial equivalence to existing devices, ensuring that you meet FDA requirements effectively. By analyzing key features and comparing them with predicate devices, the Argument Builder helps you construct compelling narratives that enhance the likelihood of regulatory success. With its user-friendly interface and powerful analytical capabilities, regulatory professionals can confidently submit applications that stand out in the approval process.