Build a stronger documentation foundation for AI-enabled medical devices with this FDA Guidance & Good Machine Learning Practice (GMLP) Essentials Document Template Package. This curated set includes editable Word and Excel templates for quality, design, risk management, data governance, validation, cybersecurity, labeling, monitoring, postmarket activities, and change control.

Designed for regulatory, quality, engineering, product, and compliance teams, this package gives you a practical starting point for creating more organized FDA/GMLP-oriented documentation without starting from a blank page.

Includes templates for an AI/ML quality manual or QMS addendum, design and development plan, intended use and ODD specification, risk management file, data governance plan, dataset specification, bias and generalizability assessment, model development plan, training traceability record, configuration management, V&V plan/report, clinical evaluation, human factors, cybersecurity documentation, labeling/IFU, complaint handling/CAPA, postmarket monitoring, and change control.

Editable files. Digital download. These materials are not legal advice, do not guarantee compliance, and are not affiliated with or endorsed by the FDA or any regulator. Provided as is, with no warranty. License is for single-buyer internal business use only; resale, redistribution, sublicensing, or file sharing is not permitted.