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SOLUTIONS · CERTIFICATION PREP

Run the audit your registrar will run.
Before they write it up.

A nonconformity found in prep is a procedure you revise on your own clock. The same nonconformity found on audit day is a written NC, a 60-day CAR, and a closure they verify on theirs. Aligntra reads your QMS against the standard the way an auditor would — clause by clause, cited to the paragraph — so you find them while they're still cheap. No sampling, 30 minutes.

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STAGE 2 · SURVEILLANCE · RECERT 100% COVERAGE · NO SAMPLING WE PREP · WE DON'T CERTIFY
finding #3902 · cert readiness MAJOR NC
ISO 13485 · §7.3.9 · DESIGN CHANGES

Design-change control doesn't require re-verification of affected outputs.

The exact gap a registrar opens at Stage 2. Better to find it now than on the audit floor.

What the standard requires
"…design and development changes shall be… verified and validated, as appropriate, and approved before implementation… the review shall include evaluation of the effect of the changes on… product already delivered."
What your SOP says

"Design changes are reviewed and approved by the design lead." — SOP-DC-007 §5.4. The procedure approves changes but never requires re-verification of affected outputs or assessment of delivered product. Cited to the paragraph.

Know what the registrar will find — first
EVERY CLAUSE, CITED
Audit typeCERTIFICATION READINESS
Applies toSTAGE 2 · SURVEILLANCE · RECERT
Coverage100% · NO SAMPLING
Run time30 MIN
FIND IT HERE. NOT THERE.

The same finding costs nothing in prep — and a quarter on the floor.

A Major NC doesn't change between your conference room and the audit floor. What changes is who's holding the clock when it's found.

In prep · with Aligntra · ~6 weeks out CAUGHT EARLY
Surfaced
§7.3.9 design-change gap, cited to your SOP
Fixed
Procedure revised, re-verification added
Re-run clean
Unchanged documents never re-billed
Audit day
You walk in green — no surprise, no clock
On the floor · no prep · audit day WRITTEN UP
Audit day
Same §7.3.9 gap — found by the registrar
NC written
Major NC on the report you sign
60-day clock
CAR response due — root cause + evidence
Re-visit
Closure verified — on their schedule

Same finding. The only variable is whether you read it first.

THE DELIVERABLE THEY READ

What prep actually hands you.

Not a readiness score with no receipts. The findings the registrar would open, in the format the registrar reads — so closing them is a to-do list, not a translation exercise.

Find it first

The nonconformities, before the audit.

Clause-by-clause verdicts — compliant, observation, Major/Minor NC — across 100% of your in-scope documents. The findings a registrar would open, surfaced while you can still fix them.

Auditor-format exports

Excel + PDF, the way auditors read them.

Page-precise citations, NCs and OFIs classified per ISO 19011, marked-up PDFs with findings highlighted in the source document. No re-typing.

Re-run as you close

Watch readiness climb, not guess at it.

Fix a procedure, re-run, confirm the NC is closed — unchanged documents are never re-billed. Walk into Stage 2 knowing exactly where you stand.

WHERE THE LINE IS

We prep. We don't certify.

Aligntra is not a certification body, a registrar, or a notified body — it issues no certificates and confers no conformity. It reads your QMS against the standard the way an auditor would, so the registrar's audit holds no surprises. We make the homework honest. They still grade the test.

Know what your registrar will find — in 30 minutes.

Bring a folder of your own procedures, or run a live audit on a published example QMS we maintain. Find the findings while they're still yours to close.

Book a 30-min demo → See pricing