Consulting Services

From gap analysis to certification

Q: 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 consultants close those gaps. Many teams use both.

Q: 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.

Q: Do we need the platform to use consulting services?

All consulting engagements include platform access. This is how our consultants work - AI analysis provides the foundation, consulting executes on those findings. It's what makes us faster and more cost-effective.

Q: 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.

Q: 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.

Traditional consultants spend weeks reading your documents. Ours start with your complete AI gap analysis.

Schedule a free consultation

How it works

Analysis to certification

Step 1 — Platform

AI Gap Analysis

Upload your QMS documents
AI analyzes against your target standard
Every gap mapped to exact clauses
Prioritized findings report

Complete visibility — before a consultant touches it

Step 2 — Consulting

Remediation

Write and fix documentation
Build processes from scratch
Mock audits and preparation
On-site audit support*

Audit-ready — remediation-complete

*On-site engagements may incur additional travel expenses based on location.

The difference

Consultants who start with answers

Traditional consultants spend weeks reading documents. Ours start with complete analysis.

No discovery phase

AI analysis is complete before consultants begin. Every hour goes to execution.

Evidence-based remediation

Every fix ties to specific gaps with exact clause references. No guesswork.

Seamless handoff

Platform and consulting work together. Findings flow directly into remediation plans.

Lower total cost

Eliminate the traditional discovery overhead. Your engagement starts with actionable findings.

Services

Expert support at every stage

Gap Assessment

Start here

Platform analysis plus expert review. Complete picture of your compliance status with prioritized remediation plan.

Internal Audits

Certified Lead Auditors conduct thorough internal audits that satisfy ISO 13485, AS9100D, and ISO 9001 requirements.

QMS Documentation

Quality manuals, SOPs, work instructions, and forms. Compliant documentation that works.

Audit Preparation

Get your team and documentation ready for Notified Body audits or FDA inspections.

Fractional QA/RA

Senior quality and regulatory expertise on retainer. Support without the full-time cost.

Mock Audits

Experience your certification audit before the real thing with detailed feedback.

Comparison

Platform vs. Platform + Consulting

Comparison of Platform-only vs. Platform + Consulting by situation
Your situation	Platform only	Platform + Consulting
Have internal QA/RA team	Good fit	Accelerates major projects
No internal QA/RA expertise	Identifies gaps	Best fit — we handle everything
Building QMS from scratch	SOP Builder creates docs — QA/RA expertise needed	Best fit — we build it right
Audit in 30-60 days	Risk if major gaps	Best fit — we execute fast
Post-audit remediation	Shows what's wrong	Best fit — we close findings

Have internal QA/RA team

Platform onlyGood fit

+ ConsultingAccelerates major projects

No internal QA/RA expertise

Platform onlyIdentifies gaps

+ ConsultingWe handle everything

Building QMS from scratch

Platform onlySOP Builder + your QA/RA team

+ ConsultingWe build it right

Audit in 30-60 days

Platform onlyRisk if major gaps

+ ConsultingWe execute fast

Post-audit remediation

Platform onlyShows what's wrong

+ ConsultingWe close findings

Talk to a consultant

No commitment. 30-minute call.

FAQ

Common questions

What if we already use Greenlight Guru or Qualio?

Can you help us get ISO 13485 certified?

Do we need the platform to use consulting services?

What if we just want to use the platform ourselves?

Do you support standards beyond medical devices?

Engagement details

Timeline

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.

Pricing

Gap assessments are fixed-fee projects starting at $2,500. Remediation and ongoing support are scoped after the assessment. We provide a detailed proposal before any commitment.

Process

Start with a 30-minute consultation. We run the AI gap analysis within the first week, then deliver a prioritized remediation plan — documentation fixes, process builds, mock audits, and audit preparation.

Start with answers, not questions

Our consultants review your complete AI gap analysis before your first call. No discovery phase, no wasted time.

Schedule a free consultation

Have internal QA/RA expertise? Start with the platform yourself →