Medesta — AI-assisted eQMS for medical devices

The eQMS that finds your compliance gaps — and drafts the fixes.

FDA + EU MDR in one unified, framework-tagged checklist.
AI drafts the gaps — every claim cited, confidence scored.
Immutable versions, append-only audit, e-sign — 21 CFR Part 11-ready.

Assistive, never authoritative. Nothing is approved without a human sign-off.

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FDA QMSR + EU MDR · AI-assisted · human-in-the-loop