Streamline internal reviews for AI-enabled medical devices with this FDA Guidance & Good Machine Learning Practice (GMLP) Compliance Checklist Package. This practical bundle includes an editable Word checklist with sign-off boxes and an Excel tracker for pass/fail status, owners, evidence links, remediation follow-up, and audit notes. Built for quality, regulatory, engineering, product, and compliance teams, it helps organize lifecycle controls across governance, data management, model development, validation, risk management, cybersecurity, transparency, postmarket monitoring, and change control. Use it to support audit preparation, documentation reviews, submission readiness, and ongoing compliance workflows. The files are fully editable, easy to adapt, and designed to make reviews more consistent and actionable. Need the underlying documentation too? Pair this package with the FDA GMLP Full Document Template Package for the matching policies, plans, procedures, matrices, and supporting templates. These materials are not legal advice, do not guarantee compliance, and are not a substitute for legal, regulatory, clinical, or quality counsel. Not affiliated with or endorsed by the FDA or any regulator. Provided as is, with no warranty. License: single buyer license for internal business use only; no resale, redistribution, sublicensing, or sharing of the files in original or modified form.