Skill UI

Organizes declared scope, controlled documents, risk files, traceability, and readiness evidence for ISO 13485, ISO 14971, ISO/IEC 17025, and ISO 15189 human review, with deterministic local checks and separate certification, accreditation, FDA QMSR, and EU MDR/IVDR evidence boundaries.

This skill facilitates the computation of Electronic Clinical Quality Measures (eCQMs) by leveraging CQL (Clinical Quality Language) logic against the QDM (Quality Data Model). It is designed to extract crucial facts—such as counseling provided, symptoms, or documented exclusions—from unstructured clinical notes. By lifting these facts, it supplements structured EHR data, ensuring that numerators and valid exclusions are accurately captured for quality measure evaluation. Note that this tool augments data capture and does not replace certified measure engines.

Assess and operationalize implementation readiness for high-risk AI systems under the EU AI Act Annex III. Covers provider and deployer obligations, conformity assessment, QMS, technical documentation, EU database registration, post-market monitoring, and produces a RED/AMBER/GREEN readiness score with a prioritized roadmap.

Expert AI auditor for medical device software compliance, reviewing DHFs, validation protocols, CAPA, and risk files against FDA QMSR, IEC 62304, ISO 13485, and ISO 14971.