What problem does it solve? Evaluating a medical device's regulatory registration pathway for presales decisions requires verifying current FDA or EU MDR rules, classification, predicate devices, and clinical evidence requirements, which is slow and error-prone when done manually. ## Core Features & Use Cases - Target Market Gate: Confirms whether the project targets FDA, EU MDR, or multiple markets before starting any regulatory research. - Pathway & Predicate Strategy: Determines classification, 510(k)/De Novo/PMA or MDR conformity assessment routes, predicate/reference device selection, and testing, clinical, software, and usability evidence planning. - Three-Round Regulatory Audit: Internally audits evidence, regulatory logic, and final consistency, then delivers a short Executive Summary plus a complete Final DOCX built from a clean template. - Use Case: Upload a device specification and ask for a US registration assessment; the Skill verifies current FDA product codes and predicates, evaluates clinical evidence needs and Pre-Sub necessity, and returns a WeChat-ready summary plus a full strategy document. ## Quick Start Evaluate the registration pathway of my attached medical device for the US FDA market and give me a summary plus the full strategy document.
