Medical Devices & MedTech

– AI-empowered eQMS for ISO 13485 & 21 CFR 820
– Link Quality Events → CAPA → Controlled Change → Documents/Training with assistive AI, in-region hosting, and committed uptime.

Who it’s for?

  • QA/RA.
  • CAPA Owners.
  • Manufacturing/Operations.
  • Design Quality.
  • Auditors.

What it solves?

  • Scattered complaint/deviation/NCR info.
  • Slow investigations & filings.
  • Changes not tied to Docs/Training/LMS.
  • Approval ping-pong.

Key capabilities

  • In-region data residency + committed uptime.
  • Quality Events with built-in investigations → QA review → closure.
  • CAPA with root-cause tools, action types (user task / Doc effective / Training specifc Users), closure dependencies.
  • Controlled Change with impact/risk, stage gates, closure dependencies (tasks, verifications, Training/Doc updates).
  • Document Control (e-sign, R&U) and Training auto-assign on release/effective.
  • AI-empowered (assistive): concise summaries & suggested fields/checklists (you approve)
  • Preliminary Reviewer gates on Controlled Docs/Quality Events/CAPA/Controlled Change.
  • External Notification Recipient for partners/suppliers (read-only links) to inform relevant stakeholders in real-time and avoid external tool based communication.
  • Version & audit diffs, no hard deletion + restore, configurable labels/roles.
  • In-region data residency (USA • EU • APAC • Middle East • ANZ) + committed uptime.

Compliance

  • Built for ISO 13485 and 21 CFR 820 programs with 21 CFR Part 11–friendly e-sign (identity, time, meaning/intent).
  • Immutable, time-stamped audit trails with before/after values; read-only auditor mode; retention + restore (no hard deletion).
  • RBAC/least-privilege, status-gated external access, and traceable cross-links (Event↔CAPA↔Change↔Doc/Training).
  • Regional hosting (USA/EU/APAC/ME/ANZ) with uptime commitments.

Audit ease

  • Time-stamped, immutable audit trails with a clean, side-by-side diff so you can compare any two versions and see who changed what, when, and why.
  • Read-&-Understood ledger (identity, version, meaning).
  • OOS/OOT packets.
  • Linked chain (Quality Event→CAPA→Controlled Change→Quality Doc/Training).
  • Read-only auditor sessions.
  • Complaint/Device History dossiers.
  • Side-by-side doc diffs & approval packets.
  • Change Evidence Packs with dependency proof.

Outcomes

  • Faster closures.
  • Cleaner filings.
  • Fewer findings.
  • Traceable design/manufacture links.
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