Terms of Service

CAPA Health Check turns your inputs into pattern observations grounded in public FDA citation data and similar sources. It is not regulatory, legal, or clinical advice, and it is not a substitute for your own quality system, counsel, or consultants.

Compliance decisions

For any decision that could affect patients, product release, or regulatory posture, consult qualified counsel and qualified QA/RA professionals who know your device class, markets, and history.

Your data and IP

You keep all intellectual property rights in the content you submit. We do not ask for a perpetual license to your trade secrets. We do not sell your questionnaire answers. We use sub-processors only to operate the service (see our Privacy Policy), not to hand your data to unrelated third parties for their own purposes.

Service “as is”

The tool is provided as-is, without warranties of any kind, express or implied. Scores and narratives can be wrong, incomplete, or outdated relative to the real world. Availability may change. We may modify or discontinue features.

Contact

Questions about these terms: security@playbookbysme.com.