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:
Used by compliance teams at medical device companies and regulated industries.
Stop chasing evidence across PDFs and spreadsheets. Move to an evidence-first workflow with AI Gap Analysis.
Your procedures probably cover most requirements. But proving it means:
By the time you finish, you're behind again.
A structured, evidence-linked workflow for clause-by-clause reviews.
PDFs, Word files, Google Docs. We connect to your systems and read everything.
ISO 13485, ISO 27001, ISO 9001, MDR, or upload custom requirements in one click.
For each requirement, see what is covered, partial, or missing with reasoning.
Every answer links directly to the source document and page. You make the final call.
You're done in hours, not days.
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 compromising quality and efficiency.
This will open the document on page 14
Automated evidence discovery that runs while you do real work.
Import PDFs, connect Google Drive, or upload Word files. We handle the reading.
Choose ISO 13485, ISO 27001, ISO 9001, or custom requirements.
Our AI matches content to requirements and cites sources. Takes 2-4 hours.
See what is covered, missing, and where it lives. Export when ready.
Whether you are tackling your first certification or managing multi-framework audits at scale.
Close deals faster with your first ISO or SOC 2 certification. No consultant required for evidence hunting.
Learn moreManage ISO 13485, ISO 27001, and ISO 9001 in one place. Reuse evidence across frameworks.
Learn moreCoordinate across departments, maintain evidence trails, and prepare for surveillance audits continuously.
Contact SalesEvidence-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.
Evidence discovery, verification, and collaboration in one place.
Upload once. We read every document and extract relevant evidence automatically.
Chat with your documents and get instant answers with citations.
Click any citation to jump to the exact paragraph in the source document.
See exactly what is covered, partial, and missing for every requirement.
Share findings, assign gaps, and track remediation progress.
Export findings for auditors, management, or internal review.
Encrypted documents, private workspaces, and no AI training on your data.
ISO 13485, ISO 27001, ISO 9001, MDR, or your own requirements.
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
HTMLSecurity is a trust signal for compliance teams. We build with privacy, encryption, and auditability from the start.
All documents are protected with enterprise-grade encryption (TLS).
Your compliance documents are never used to train models.
Teams see only their own data with complete workspace isolation.
Built with privacy and data protection at the core.
We use OpenAI enterprise endpoints with enhanced privacy controls.
Subscription includes one analysis run credit each month.
Additional runs are $25 each.
For teams running their first gap analyses.
Additional analysis runs: $25 each.
For teams with advanced security, scale, and support needs.
Get clear answers before you run your first gap analysis.
Why We Built This
Teams do not usually struggle to write an answer. They struggle to prove it with traceable evidence. That means too much time spent searching PDFs, copying snippets, and debating whether evidence is strong enough for a real audit conversation.
AI Gap Analysis handles the document grind: it finds likely evidence, links to source pages, and gives you a faster first pass. Humans still make the call. The software accelerates evidence discovery and drafting. It does not replace professional judgment or regulatory advice.
Need expert validation for high-stakes work? Browse partner specialists who can pressure-test findings and help turn gaps into audit-ready actions.
Partners
AI Gap Analysis accelerates evidence discovery. Our partners help pressure-test findings, challenge weak evidence, and turn gaps into audit-ready actions.
PartnerMedical device + AI compliance across pre-market, post-market, and MDIS-enabled operations.
AI Gap Analysis finds evidence. MedQAIR consultants expand that into regulator-ready execution across SaMD/AI strategy, quality systems, economic-operator obligations, and post-market workflows.
PartnerRegulatory, quality, and clinical consulting for medical device + pharma teams.
Support across regulatory strategy, submissions, clinical, and quality systems for teams that need audit-ready documentation and clear execution.
AI Gap Analysis accelerates evidence discovery. Partner experts can validate findings, challenge weak citations, and help turn output into decisions you can defend.
Scope, availability, and pricing are set by each partner.
Practical tools and insights to help you plan MDR timelines and evidence readiness.
Estimate realistic Notified Body timelines based on your device class and readiness.
Calculate your timelineEstimate Notified Body fees and implementation costs using published fee schedules.
Estimate costsGenerate Annex II and III requirements for your device class.
Get your checklistMDR timelines, evidence strategies, and audit prep guidance delivered to your inbox.
Read the blogEvidence-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
Operator Note
We built AI Gap Analysis for teams that need to move quickly without losing rigor. Every result should be traceable back to source evidence you can inspect.
The goal is not to automate judgment. The goal is to remove low- value document hunting so experts can focus on decisions, remediation, and audit readiness.
If evidence is weak, you should challenge it. If evidence is missing, you should surface it. That is the standard this product is built around.
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.
