Manual reviews are slow
Teams spend days locating relevant clauses, checking evidence, and preparing findings for stakeholders.
Now accepting Pilot Partners
Accelerate MedTech compliance with AI.
Assess compliance in seconds across your medical device documentation. Reveal gaps, flag risks, and receive guided next steps with AI powered by regulatory expertise.
80%
faster review cycles*
100%
requirement traceability
24/7
audit readiness
The compliance bottleneck is document-heavy, manual, and hard to prove.
Most teams still compare regulations and internal documents by hand. That slows product timelines, increases review risk, and makes audit defense difficult.
Coverage is inconsistent
Without a structured requirement map, gaps and partial coverage can slip through until late stages.
Audit prep is stressful
Evidence trails are often fragmented across SOPs, policies, and shared folders when auditors ask for proof.
How ClausIQ works
A repeatable workflow that turns unstructured documents into actionable compliance outcomes.
-
1
Upload regulations and internal docs
Add standards, guidance, SOPs, and QMS artifacts in one secure workflow.
-
2
Extract atomic requirements
ClausIQ identifies explicit requirements with citations and requirement-level structure.
-
3
Map evidence and detect gaps
Each requirement is assessed against your docs with evidence excerpts and recommendations.
-
4
Review in dashboard and export
Filter findings, track status, and produce outputs for remediation and audit readiness.
Watch ClausIQ in action
Key capabilities for enterprise compliance workflows
Purpose-built for MedTech teams managing regulated document lifecycles.
Requirement extraction
- Citation-aware requirement IDs
- Mandatory / conditional classification
- Expected evidence mapping
Gap analysis
- Compliant / partial / gap statuses
- Evidence excerpts and confidence
- Clear remediation recommendations
Audit-ready dashboard
- Status overview and summaries
- Requirement-level filtering
- Shareable review outputs
See outcomes in the format teams actually use
Executive summaries for leadership and requirement-level details for reviewers.
Executive summary
Fast readiness snapshot
Understand total requirements, status distribution, and risk posture at a glance.
Requirement review
Evidence and recommendations in context
Inspect each requirement with matched evidence, gap notes, and remediation guidance.
Why teams choose ClausIQ
Built to improve speed without compromising quality, traceability, or audit confidence.
Operationally practical
Fits existing QA/RA review workflows and document governance processes.
- Works with existing policy and procedure sets
- Designed for repeatable review cycles
- Supports cross-functional collaboration
Defensible outputs
Grounded findings with citation, evidence mapping, and transparent recommendation logic.
- Requirement-level traceability
- Clear gap ownership handoff
- Audit-friendly review artifacts
Frequently asked questions
Answers for QA, RA, and leadership teams evaluating ClausIQ.
What documents can ClausIQ analyze?
Regulations and standards plus internal documentation such as SOPs, QMS procedures, work instructions, and quality records in PDF, DOCX, and TXT formats.
How do reviewers validate AI-generated findings?
Each finding includes requirement-level status, source citation, and supporting evidence excerpts so reviewers can verify outputs before sign-off.
Does ClausIQ replace QA or regulatory experts?
No. ClausIQ accelerates analysis and highlights potential gaps, while final interpretation and approval remain with your QA and RA team.
How quickly can we run a pilot?
Most teams can launch an initial pilot in days by uploading one regulation set and a core set of internal documents.
What outputs do we get for audit preparation?
You get requirement traceability, evidence mapping, gap status summaries, and reviewer-ready artifacts that support internal and external audit workflows.
Can we evaluate ClausIQ with our own documents?
Yes. Request a demo to set up a guided evaluation using your workflows, priorities, and documentation set.
Ready to modernize compliance review?
Start with a guided pilot or open the demo portal and explore the workflow yourself.