What problem does it solve? Preparing medical device technical documentation for EU MDR (Regulation 2017/745) submission requires verifying that all mandatory documents—Clinical Evaluation Reports, PMS plans, PMCF plans, SSCP—are present and complete for the device's risk class. Manual checks are error-prone and can miss critical gaps that delay regulatory approval. ## Core Features & Use Cases - Class-Based Document Checklists: Verifies required documents against device classification (I, IIa, IIb, III), including CER, PMS Plan, PMCF Plan, SSCP, and risk management files. - Content-Level Inspection: Scans CER and PMS documents for required sections such as clinical data, benefit-risk conclusions, trend reporting, and data collection methods. - Structured Compliance Reports: Outputs JSON audit reports with findings categorized as CRITICAL, MAJOR, MINOR, or INFO, plus an overall status of COMPLIANT, PARTIAL, or NON_COMPLIANT. - Use Case: Before submitting a Class IIa device technical file to a notified body, run the auditor on the documentation folder to confirm the PMCF plan and clinical evaluation report are present and complete. ## Quick Start Ask the assistant to audit your technical documentation folder for MDR compliance by specifying the folder path and device class, for example: check whether my Class IIa device technical file meets MDR requirements.
