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Consulting Services

Stop paying consultants to read.

Every engagement starts from your complete AI gap analysis — findings clause-cited before the first call. Your budget goes to fixing, not finding.

Schedule a free consultation See how an engagement runs
Run by a practicing Lead Auditor Every fix re-verified Scoped per proposal
app.aligntra.com/audits/eng-2026-014 REMEDIATION · WK 3
Finding 1 of 12 · ISO 13485:2016 MAJOR NC · §7.4.1

Suppliers are qualified after they ship — POs issued on stated capabilities.

SOP-PUR-002 · REV 04 · P.7 §5.2
Recommended fix EXECUTED BY YOUR CONSULTANT
Rewrite §5.2 — supplier evaluation precedes the PO
Document evaluation criteria per §7.4.1(a)
Update supplier file template FRM-PUR-011
Train Purchasing on SOP-PUR-002 Rev 05
Closes when the re-run reads §7.4.1 Compliant against Rev 05 RE-RUN · WK 6
Every fix, verified
ENGAGEMENTS RUN ON THE PLATFORM EVERY FIX RE-VERIFIED BY RE-ANALYSIS NDA ON REQUEST SCOPED PER PROPOSAL
The difference

Week one, two ways.

Every consulting engagement burns its first weeks on the same thing: reading. Ours doesn't, because the reading is already done.

Traditional consultant · week one

Reading your documents.

Somewhere in your document set, a consultant is building the picture you're paying them to have.

  • Document request list
  • Interviews to schedule
  • "Discovery" on the invoice
Aligntra engagement · week one

The reading is already done.

The AI run finished before the first call — every finding mapped to its clause, cited to the paragraph.

  • Findings report in hand
  • Remediation plan drafted, prioritized
  • Week one is execution
How an engagement runs

Analysis to certification, as a controlled record.

The same artifact discipline we bring to your QMS, applied to the engagement itself — every stage has a deliverable and a status.

ENGAGEMENT PLAN — TYPICAL CERTIFICATION PREPENG-2026-014
WK 0 AI gap analysisYour documents run against the standard — every clause, cited. Thirty minutes, not six weeks. DONE
WK 1 Prioritized remediation planFindings triaged Major NC → OFI; every fix gets an owner and a target revision. DONE
WK 2–6 RemediationDocumentation rewritten, processes built. Each fix re-verified by re-analysis — unchanged documents are never re-billed. IN PROGRESS
THEN Mock auditA practicing Lead Auditor runs you through it the way a registrar would — with detailed feedback. SCHEDULED
READY Registrar-readyYou walk in with the audit trail already run — and the evidence cited. TARGET

A gap assessment takes 1–2 weeks. Full certification preparation ranges from 2–6 months depending on maturity level and target standard. Urgent timelines (audit in 30–60 days) are possible with dedicated resources. On-site engagements may incur travel expenses.

Who runs your engagement

A practicing Lead Auditor, start to finish.

Every engagement is run by a practicing Lead Auditor who works in the analysis platform every day — not an account manager who subcontracts the technical work. The auditor reading your findings knows exactly how they were produced, so remediation starts the moment the gap analysis lands — no handoff, no ramp-up.

Every clause-mapping decision is one we'd defend in front of a registrar.

Engagement facts
LeadPracticing Lead Auditor — runs audits, not just engagements
StandardsISO 13485 · AS9100D · ISO 9001 · FDA QMSR · EU MDR · MDSAP
PlatformEvery engagement includes platform access — findings stay live, fixes re-verify
Paper trailEngagement records kept like controlled documents
Services

The engagement menu.

Every engagement starts from your AI gap analysis and is scoped before any commitment — you get a detailed proposal first.

ServiceWhat you getTypical timeline
GET CERTIFIED
Gap Assessment Start here Platform analysis plus expert review. Complete picture of your compliance status with prioritized remediation plan. 1–2 weeks
Remediation Documentation rewritten, processes built, findings closed — each fix re-verified by re-analysis. Scoped after assessment
Mock Audits Experience your certification audit before the real thing with detailed feedback. Per proposal
STAY READY
Internal Audit Program Your annual internal audit schedule, run end-to-end by a certified Lead Auditor — satisfying ISO 13485, AS9100D, and ISO 9001 requirements. Every report registrar-ready. Annual program
Supplier Audits Second-party audits conducted on your behalf — your supplier's documentation analyzed before the audit begins, findings cited to their procedures. Per supplier
Fractional QA/RA Senior quality and regulatory expertise on retainer — monthly hours you scale up or down. Support without the full-time cost. Monthly retainer
WHEN THINGS HAPPEN
Standard Transitions Move to a new standard or revision with the gap already mapped — your QMS run against the new text, transition plan prioritized. Current: FDA QMSR (21 CFR 820, effective Feb 2026). Time-boxed · per proposal
Audit Preparation Get your team and documentation ready for Notified Body audits or FDA inspections. Per proposal

QMS documentation (quality manuals, SOPs, work instructions, forms) is delivered inside Gap Assessment and Remediation engagements. On-site work may incur travel expenses.

Comparison

Platform vs. Platform + Consulting

Comparison of Platform-only vs. Platform + Consulting by situation
Your situation Platform only Platform + Consulting
Have internal QA/RA teamGood fitAccelerates major projects
No internal QA/RA expertiseIdentifies gapsBest fit — we handle everything
Building QMS from scratchSOP Builder creates docs — QA/RA expertise neededBest fit — we build it right
Audit in 30-60 daysRisk if major gapsBest fit — we execute fast
Post-audit remediationShows what's wrongBest fit — we close findings
FAQ

Common questions

What if we already use Greenlight Guru or Qualio?
They're complementary. Greenlight Guru and Qualio help you manage QMS documents. Aligntra analyzes them for compliance gaps, and our consulting engagements close those gaps. Many teams use both.
Can you help us get ISO 13485 certified?
Yes. We prepare you for certification — gap assessment, documentation, internal audits, and mock audits. The actual certification audit must be conducted by an accredited Certification Body, but we get you ready to pass.
Do we need the platform to use consulting services?
All consulting engagements include platform access. This is how every engagement works — AI analysis provides the foundation, consulting executes on those findings. It's what makes us faster and more cost-effective.
What if we just want to use the platform ourselves?
That works great if you have internal QA/RA expertise. The platform identifies every gap with exact evidence. Your team uses those findings to remediate. You can start platform-only and add consulting when needed.
What does Fractional QA/RA include?
Senior quality and regulatory expertise on a monthly retainer — hours you scale up or down as needs change, with priority access for urgent questions. Scope and hours are set in your proposal.
How is an engagement priced?
Every engagement is scoped individually — we run the AI gap analysis, then provide a detailed fixed-scope proposal before any commitment. No hourly surprises, no open-ended discovery.
Do you support standards beyond medical devices?
Yes. We support ISO 9001, AS9100D for aerospace, and ISO 14971 in addition to medical device standards like ISO 13485, FDA QMSR, EU MDR, and MDSAP. The platform and consulting services cover any of these standards.

Start with answers, not questions

Every engagement starts from your complete AI gap analysis — reviewed before your first call. No discovery phase, no wasted time.

Schedule a free consultation

Have internal QA/RA expertise? Book a platform demo →