AI-powered MedTech compliance
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Find and fix gaps confidently with Klaris
Trusted by Regulatory Teams at
Trusted by regulatory teams at
SECURE AND PRIVATE
BY DEFAULT
Our information security management system is independently certified to ISO/IEC 27001:2022 standards.
Fully compliant with EU/UK GDPR. We process data in EU/UK regions and offer DPA upon request.
Your data is encrypted in transit (TLS 1.3) and at rest (AES-256). We maintain strict access controls.
Our information security management system is independently certified to ISO/IEC 27001:2022 standards.
Fully compliant with EU/UK GDPR. We process data in EU/UK regions and offer DPA upon request.
Your data is encrypted in transit (TLS 1.3) and at rest (AES-256). We maintain strict access controls.
Automated Compliance Check
Stop second-guessing your technical documentation.
Klaris checks against hundreds of expert-validated requirements, filtered for your device characteristics.
Did I miss anything?
Upload your documentation. Klaris maps it against applicable requirements and shows gaps with clear reasoning you can verify.
Where's the evidence?
Every finding links to your documentation. Every requirement traces to the exact clause, annex, or reference.
Are we still compliant?
Re-run gap analysis after regulation changes. Compare before and after.
How can we close the gap?
Each finding includes remediation guidance. Prioritize what matters before your deadline.
Full Coverage for EU MDR 2017/745 Click to expand
RESPONSIBLE AI
BY DESIGN
Requirements are written and validated by regulatory specialists, not hallucinated by AI.
Zero data retention policy with major LLM providers. Your proprietary IP never trains LLM models.
Klaris operates as a Low-Risk AI System Deployer, fully compliant with the EU AI Act rules.
Requirements are written and validated by regulatory specialists, not hallucinated by AI.
Zero data retention policy with major LLM providers. Your proprietary IP never trains LLM models.
Klaris operates as a Low-Risk AI System Deployer, fully compliant with the EU AI Act rules.
Automated Consistency Check
Stop hunting through documents.
Klaris flags deviations from your source definitions across all your documents.
Does everything still match?
Compare side-by-side with differences highlighted and clear reasoning for each deviation.
What's affected if I change this?
Update a definition. Klaris shows every document that references it and flags mismatches.
Did all documents get updated?
See which files were revised and which still contain old text. No manual tracking required.
What drifted?
Documents diverge over time. Klaris surfaces drift before it becomes a non-conformity.
How many gaps are hiding
in your documentation?
Design Freeze
Identify gaps during R&D. Get real-time feedback as your team drafts.
Before Submission
Run the 'Golden Copy' check. Ensure documentation is complete.
PRRC Sign-Off
Give your PRRC the evidence they need to confirm the file is complete.
Before Audit
Know your gaps before the auditor arrives. Create a remediation plan.
New Regulation
ISO or MDCG guidance updated? Instantly check which documents need revision.
OPERATE WITH CONFIDENCE
EVERY TIME.
Forward-looking
teams use Klaris
"Although three people had reviewed our technical documentation, Klaris found 10+ potential non conformities one week before submission."
"I am quite surprised with the general level of expertise the AI is showing."
"The platform is absolutely simple, easy, and understandable."
"Very valid gap analysis for our risk management."
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Upload Files
Drag & drop .docx, .xlsx, .pdf securely.
AI Review
Instant compliance & consistency checks.
Take Action
Fix findings with expert guidance.