Reduce audit prep time with evidence-linked gap analysis
QA teams lose 3-6 hours per framework just finding evidence. Auditors ask follow-up questions. Documents change. You start over. Stop playing document detective.
AI Gap Analysis gives you:
- 3-6 hours First-pass coverage view
- 0% of findings linked to document + page number
- 0% less time hunting for evidence
Used by compliance teams at medical device companies and regulated industries.
Old way vs. new way
Stop chasing evidence across PDFs and spreadsheets. Move to an evidence-first workflow with AI Gap Analysis.
The evidence hunt that won't end
Your procedures probably cover most requirements. But proving it means:
- Clause cross-referencingManually cross-referencing hundreds of pages against framework clauses
- Spreadsheet copy-pasteCopying snippets into spreadsheets, losing track of versions
- Evidence uncertaintySecond-guessing whether a paragraph actually addresses the requirement
- Rework on updatesStarting over when procedures change
- No audit-ready trailEvidence links break and confidence drops under review
- Chat-based reviews don't scaleUsing ChatGPT for clause checks turns into long, fragmented threads with no reliable overview, weak traceability to document names and page numbers, and work that is hard to reuse when documents change
By the time you finish, you're behind again.
What you get with AI Gap Analysis
A structured, evidence-linked workflow for clause-by-clause reviews.
Upload your documents
PDFs, Word files, Google Docs. We connect to your systems and read everything.
Select your framework
ISO 13485, ISO 27001, ISO 9001, MDR, or upload custom requirements in one click.
Get evidence-backed findings
For each requirement, see what is covered, partial, or missing with reasoning.
- Covered - exact quote and page
- Partial - evidence plus identified gaps
- Missing - no matching content
Verify in seconds
Every answer links directly to the source document and page. You make the final call.
You're done in hours, not days.
See the evidence yourself
Every finding includes the full audit trail so you can verify instantly.
Easy links back to the source document and exact page, so you can check it in seconds. Validating the evidence, with clear references you can defend.
Derisk without comprimising quality and efficiency.
This will open the document on page 14
From documents to audit-ready in four steps
Automated evidence discovery that runs while you do real work.
- 1
Upload
Import PDFs, connect Google Drive, or upload Word files. We handle the reading.
- 2
Select
Choose ISO 13485, ISO 27001, ISO 9001, or custom requirements.
- 3
Analysis runs
Our AI matches content to requirements and cites sources. Takes 2-4 hours.
- 4
Review findings
See what is covered, missing, and where it lives. Export when ready.
Built for every compliance scenario
Whether you are tackling your first certification or managing multi-framework audits at scale.
First-time compliance
Close deals faster with your first ISO or SOC 2 certification. No consultant required for evidence hunting.
Learn moreMulti-framework compliance
Manage ISO 13485, ISO 27001, and ISO 9001 in one place. Reuse evidence across frameworks.
Learn moreAudit preparation at scale
Coordinate across departments, maintain evidence trails, and prepare for surveillance audits continuously.
Contact SalesTrusted by compliance professionals
Evidence-backed workflows used by auditors and regulatory teams.
This tool has completely transformed the way I audit. It automates searching for evidence and links exactly where it is located. This enables me to deliver stronger compliance outcomes for clients.
I went from a pile of PDFs to audit-ready findings before lunch. Now I can focus on the real work.
I used to go clause by clause manually. Now I review the AI answer, check the citation, and move on.
Everything you need for faster compliance
Evidence discovery, verification, and collaboration in one place.
Automated Evidence Collection
Upload once. We read every document and extract relevant evidence automatically.
AI-Powered Search
Chat with your documents and get instant answers with citations.
Direct Page Links
Click any citation to jump to the exact paragraph in the source document.
Gap Identification
See exactly what is covered, partial, and missing for every requirement.
Team Collaboration
Share findings, assign gaps, and track remediation progress.
Audit-Ready Reports
Export findings for auditors, management, or internal review.
Secure & Private
Encrypted documents, private workspaces, and no AI training on your data.
Framework Flexibility
ISO 13485, ISO 27001, ISO 9001, MDR, or your own requirements.
Connect tools and file types instantly
Direct imports from Google Drive, Confluence, and Matrix Requirements. Upload PDFs, TXT, MD, CSV, JSON, and HTML files with evidence preserved.
We already support Google Drive, Confluence, and Matrix Requirements, and we're happy to add more. If your tool exposes a usable API, we can usually build an integration and keep it working as your documents change. If it doesn't connect directly but lets you export files, we can also set up a simple custom upload flow for that. Email Eric (founder) and we'll take a look.
PDF
TXT
MD
CSV
JSON
HTMLYour data stays private
Security is a trust signal for compliance teams. We build with privacy, encryption, and auditability from the start.
Encryption at rest and in transit
All documents are protected with enterprise-grade encryption (TLS).
No AI training on your data
Your compliance documents are never used to train models.
Row-level security
Teams see only their own data with complete workspace isolation.
GDPR compliant
Built with privacy and data protection at the core.
Enterprise APIs
We use OpenAI enterprise endpoints with enhanced privacy controls.
Simple, transparent pricing
Subscription includes one analysis run credit each month.
Additional runs are $25 each.
For teams running their first gap analyses.
- 1 gap analysis run credit per month
- Unlimited document uploads
- AI chat with your documents
- AI-powered document search
- ISO 13485, ISO 27001, ISO 9001, and more
- Google Drive, Confluence, and Matrix Requirements integration
- Team collaboration
- Secure workspace
Additional analysis runs: $25 each.
For teams with advanced security, scale, and support needs.
- 50+ seats
- Custom frameworks
- SSO/SAML authentication
- API access
- Dedicated support
- Service-level agreements
Common questions
Get clear answers before you run your first gap analysis.
Why we built this
Compliance work is slow because the hard part isn’t answering a clause, it’s proving it. People spend hours digging through PDFs, copying snippets, and second‑guessing whether a procedure counts as evidence. We built an agent that does the boring part: it finds the right paragraphs, quotes them, and links straight to the page. You keep control of the judgement calls. Our product accelerates evidence discovery and drafting. But it does not fully replace professional judgement or regulatory advice.
Tools accelerate evidence discovery. Audits still require professional judgment. MedQAIR's compliance consultants can review AI findings, challenge weak evidence, and help prepare audit-ready conclusions.
We build the tool. MedQAIR provides the human judgment. For high-stakes audits, this combination delivers speed and validation.
Want human validation? Partner with MedQAIR compliance consultants for professional review of AI findings.
The experts
MedQAIR's compliance consultants support your audit prep and help validate the evidence trail. For early customers, expert review can be added per engagement.
MedQAIR Expert Review
Add a human validation layer when you want it.
AI Gap Analysis works self-serve: clause-by-clause evidence with direct page links, so you can verify findings fast and make the final call. If you want extra confidence, book a MedQAIR consultant to pressure-test your results and turn them into audit-ready actions.
Includes a 1-hour review of your results. If more time is needed, we align with you first and only proceed with approval.
Citations + expert challenge + a clear plan for closing gaps.
Not ready to start? Try these free resources
Practical tools and insights to help you plan MDR timelines and evidence readiness.
MDR Timeline Calculator
Estimate realistic Notified Body timelines based on your device class and readiness.
Calculate your timelineMDR Cost Calculator
Estimate Notified Body fees and implementation costs using published fee schedules.
Estimate costsTechnical Documentation Checklist
Generate Annex II and III requirements for your device class.
Get your checklistWeekly Compliance Insights
MDR timelines, evidence strategies, and audit prep guidance delivered to your inbox.
Read the blogProof in the numbers
Evidence-first workflows help teams move faster with confidence.
Average time to complete a full gap analysis
Evidence reuse across frameworks
Average verification time per requirement
Get audit-ready faster
Upload your documents and run your first gap analysis. See clause-by-clause findings with evidence you can verify in seconds.
Subscription includes 1 analysis run credit. Additional runs are $25 each.