For medical device CMs

ISO 13485-ready for the contract manufacturer, not the device maker.

Medical device contract manufacturers (CMs) live in a specific niche: they don't own the device design, but their build records get scrutinized by the device maker's auditor as part of supplier control. You need ISO 13485 audit readiness without the full Class III burden. Ignite Lean is that middle ground.

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ISO 13485 audit readiness

The clauses your customer's auditor will name.

When a Class II/III device maker audits you as a supplier, they're looking for ISO 13485 evidence in your QMS even though you aren't the device of record. Document control (§4.2), traceability (§7.5.9), CAPA (§8.5.2), management review (§5.6), supplier control (§7.4), and risk per the device family. Ignite Lean ships all of these.

  • Document control §4.2 — versioned WIs with attributed publish
  • Traceability §7.5.9 — kit + serial chain end-to-end
  • CAPA §8.5.2 — root cause + corrective + preventive + effectiveness check
  • Management review §5.6 — quarterly review pack auto-generated
  • Supplier control §7.4 — approved supplier list + SCAR
  • Risk-aware NC field — flag impact to device safety
Contract-manufacturer traceability

Every component to every serial to every customer PO.

The device maker who hired you as a CM will trace any field event back to a component lot. You need the answer in minutes, not days. Ignite Lean captures every consumed component at the scan, ties it to the parent serial, ties the serial to the customer PO, ties the PO to the date. Reverse and forward lookups in one click.

  • Component scan at every build step — manufacturer lot captured
  • Reverse lookup: lot recall → "which serials consumed this lot?"
  • Forward lookup: customer field event → "what lots are in this serial?"
  • Customer-facing CoC export — print or share-link
  • Audit-day mode — read-only, print-friendly, traceability-first
Document control on the floor

The WI on the kiosk IS the document of record.

ISO 13485 §7.5 demands controlled documents on the manufacturing floor. Ignite Lean's versioned WI flow IS the document control system. The kiosk always shows the latest published version. The auditor asks "what version was on the floor when this lot was built?" — answer in the build record, with a snapshot of the rendered WI at that version. No drift possible.

  • WI version locked to the build record at the moment of build
  • Kiosk always shows the latest published version (no stale revisions)
  • WI snapshot stored per version — JSON + rendered PNG
  • Operator training acknowledgment per WI version
  • Promote-to-publish requires attributed sign-off (hash-chain e-sig)
Priced for contract manufacturers, not device makers

$49/seat. Not Class III enterprise pricing.

MasterControl and Greenlight Guru are priced for Class II/III device makers who carry full FDA inspection burden. As a CM, you don't. Buying that level of QMS is over-paying for risk you don't carry. Ignite Lean is calibrated for your actual exposure: ISO 13485 audit readiness through your customer's supplier-control program, at industrial-SMB pricing.

  • $49/seat all-in. Operators + viewers free
  • No Part 11 strict-mode overhead you don't need
  • Quality + production + maintenance in one bill
  • Deploys in days, audit-ready in 60-90 days
When this is NOT for you

Honest scope.

If you're the device of record (you OWN the 510(k), the DHF, the risk file), Ignite Lean is NOT the right tool for the design-control workflows you carry. Greenlight Guru is built for that exact buyer. For Class III high-risk devices under active FDA inspection, you want MasterControl-grade Part 11 strict mode. Don't over-buy from us; don't under-buy from them.

  • NOT for device-of-record makers (Class II/III with active 510(k))
  • NOT a replacement for Greenlight Guru's design-control workflows
  • NOT for FDA Class III under strict-mode Part 11 inspection
  • IS for medical device contract manufacturers (CMs / packagers / sterilizers)
Explore the platform

The rest of Ignite Lean

Design

Lay out the plant and sequence every station before a unit moves.

Execute

Run every build from any tablet, with the operator at the center.

Supervise

See the whole floor live and act on it from one screen.

Insights

Know where the line is slow and trace every unit you build.

Compliance

A full ISO 9001:2015 QMS on the same tablet — CAPA, audits, complaints, calibration, training.

Maintenance

A full CMMS on the same tablet — assets, work orders, PMs, parts, vendors, MTBF / MTTR.

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Free during early access — 1 manager seat included, unlimited operators.

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