Find and fix gaps in your technical documentation before your reviewer does.
Klaris reviews your documents line by line against requirements, clause by clause. Every gap is traceable and includes a concrete remediation.
Trusted by regulatory teams at
Catch gaps
at every stage of your journey.
A round of questions with your Notified Body can add months to your timeline. Klaris catches gaps and helps you address them before they can become a problem.
- 01
Building TD
Klaris identifies gaps in your technical documentation while you're building it.
- 02
Pre-submission
Klaris conducts a thorough review of your technical documentation before submission to the Notified Body (or FDA), preventing rounds of questions and saving time.
- 03
PRRC approval
Klaris provides a defensible, traceable evidence trail for your PRRC to approve.
- 04
Certificate renewal
Klaris helps you surface gaps in your technical documentation ahead of a certificate renewal, and walk in with a remediation plan.
- 05
Regulatory monitoring
Klaris monitors updates to regulatory requirements and checks if you remain compliant.
Your IP stays secure.
We follow the highest bar for information security.
Visit our Trust Center ISO 27001 Certified
Information security management system independently certified according to ISO/IEC 27001:2022.
GDPR Compliant
Fully compliant with EU/UK GDPR. DPA available on request.
End-to-End Encryption
Data encrypted in transit (TLS 1.3) and at rest (AES-256). Strict access controls.
EU Data Residency
Resides in the EU (Belgium); managed in the EU and UK.
Every clause checked. Every gap cited.
Klaris checks against hundreds of expert-validated requirements, filtered for your device characteristics.
Klaris Regulatory Reviewer 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 gap links to your documentation. Every requirement traces to the exact clause, annex, or reference.
Did our fixes hold?
Re-run the review on the same file after each round of edits. Compare before and after, so a fix in one place never opens a gap in another.
How can we close the gap?
Each gap includes remediation guidance. Prioritize what matters before your deadline.
Full Coverage for EU MDR 2017/745 Technical Documentation
You (and our experts) stay in control.
We believe AI should do the work, not the judgment.
Curated by Experts
Requirements are written and validated by regulatory experts, not hallucinated by AI.
No Model Training
Zero data retention contracts with major LLM providers. Your proprietary IP never trains third party models or our models.
EU AI Act Compliant
Klaris operates as a Low-Risk AI System Deployer under EU AI Act.
Grounded and Traceable
Every gap is traceable to the exact clause, paragraph, or document it came from. No black-box hallucinations.
Surface documentation drift before submission.
Your technical documentation should tell one story. Klaris flags every place your documents disagree, across every file, before you submit.
Is the key information consistent across my documents?
Klaris pinpoints exactly where your documentation conflicts, and explains every flag with clear reasoning.
What's affected if I change this?
Update one definition and Klaris shows every document that references it, flagging each mismatch.
Did every document get updated?
See which files were revised and which still carry the old text. No manual tracking.
Has anything drifted?
Documents diverge over time. Klaris surfaces the contradictions before they become a finding.
With Klaris,
thorough and fast stop being a trade-off.
Book a demo
Regulatory teams worldwide move faster with 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."
- 01
Upload
Drag & drop .docx, .xlsx, .pdf securely.
- 02
Klaris review
Get feedback in a few hours not months.
- 03
Remediate
Address gaps with expert guidance.
Discover Klaris, one platform, from gap to fix.
Regulatory review, gap assessment, and cross-file consistency, with remediation drafted for every gap.
Your ISO 10993-1:2025 review, with suggested remediation actions, in hours, not months.
Klaris reviews your biological evaluation against ISO 10993-1:2025 in hours. Every gap cites a clause and a drafted fix, for both EU MDR 2017/745 and FDA.
See the product page →Questions teams ask before their first review.
What is Klaris?
Klaris is a submission review for medical-device Technical Documentation. You upload your documents and in a few hours you get a structured report with each gap anchored to the exact clause, plus a suggested remediation for every gap. Two engines run on every document: Klaris Regulatory Reviewer checks each document against an expert-built requirement library; Klaris Consistency Reviewer cross-checks documents against each other for drift. Klaris reviews what you have written. It does not draft new content.
Is there a human accountable? Will Klaris take my job?
Klaris is built to help regulatory teams be more in control, not to replace them. Regulatory teams remain fully responsible for final decisions; AI does the work, humans do the judgment. Klaris has two delivery modes. Klaris + Your Experts: your regulatory team reviews the gaps that Klaris produced. Klaris + Our Experts: our senior regulatory experts review and counter-sign the gap analysis.
How does Klaris differ from GenAI like ChatGPT?
Generic AI tools draft text. Klaris is purpose-built for MedTech and reviews what you have already written. Every gap cites the exact passage, page, and clause, linked to a requirement authored by a senior expert (no invented clauses). The requirement library is versioned and locked to the edition you are submitting against, so reviews are reproducible by architecture: same documents in, same gaps out. Zero data retention, contracted in writing with every model provider.
What regulations does Klaris support?
Klaris covers EU MDR 2017/745 across: Annex I GSPR, Clinical Evaluation, Post-Market Surveillance, Risk Management, Labeling, Design and Manufacturing, Usability, Device Description, Declarations. Plus FDA biocompatibility (ISO 10993-1:2025). Broader FDA 510(k) coverage is on the roadmap. The Consistency Reviewer is regulation-agnostic and works on any documentation set.
How does Klaris work?
You upload your documentation as PDF, DOCX, or XLSX. Klaris reads each document against a library of 1,000+ expert-validated requirements, filtered for your device's risk class, intended use, and characteristics. You get a report back in a few hours with every gap anchored to the exact clause, the location in your document, and a drafted remediation ready to use.
Does Klaris guarantee approval or replace a Notified Body or the FDA?
No. Klaris is a pre-submission review and quality assurance tool. It helps you find and fix gaps before submission so the review can focus on judgment calls rather than documentation drift. The Notified Body and/or FDA perform the official review and issue certification/approval.
What does Klaris not do?
Klaris does not draft new content. It does not make the intended-use judgment call, generate your risk table from scratch, perform the clinical evaluation, or replace the Person Responsible for Regulatory Compliance. It does not issue certification or replace your Notified Body. The job Klaris owns is the clause-by-clause checking and the cross-document consistency pass: the work that drains senior attention without using senior judgment.
Can Klaris check consistency between the CER, IFU, and Risk Table?
Yes. This is our most popular use case. Klaris detects discrepancies by ensuring that clinical claims in your CER match the intended use in your IFU and the residual risks in your Risk Management File (ISO 14971:2019).
How does Klaris avoid hallucinated citations, and are reviews reproducible from one submission to the next?
Every gap links back to the clause definition that triggered it (authored by a senior expert, dated and versioned) and to the exact text in your document it was anchored to. Klaris' job is to match your text to a clause definition an expert already wrote; it does not decide what a clause means at review time. You get the same gaps for the same documents.
Does Klaris train AI on my data?
No. Klaris has a strict zero-data-retention policy contracted in writing with every model provider in our stack. Your documents are never used to train any model.
How does Klaris secure my data?
Klaris is ISO/IEC 27001:2022 certified, third-party audited against an independent information-security management system. Documents are encrypted in transit and at rest, live only for the duration of the review, and are never used to train any model. The full register of controls and sub-processors is published at trust.klaris.ai.
Is Klaris GDPR compliant?
Yes. Data is processed in EU/UK regions only. Data Processing Agreements are available on request.
What file formats does Klaris accept?
PDF, DOCX, and XLSX. Drag and drop any documentation into the Klaris workspace. No special formatting, no templates to fill in.
How fast can we start?
30 minutes. We run a quick onboarding call to configure Klaris for your device and your documentation. After that you are completely autonomous: upload your documentation and the report comes back within a few hours. No installation, no IT setup.
How long does a Klaris review take?
A few hours. Upload your documents and the clause-cited report typically lands the same day, compared to weeks or months for traditional manual review.
What is Klaris pricing?
Book a demo to discover more about it. We launched transparent pricing for biological evaluation review and remediation; you can check the pricing at the product page.
Does Klaris integrate with my QMS?
No integration needed. Export your Technical Documentation from whatever QMS you use and drop it into the Klaris workspace as PDF, DOCX, or XLSX. No templates to fill, no reformatting. Klaris is QMS-agnostic and works alongside Qualio, Greenlight Guru, SharePoint, Box, or anything else you run.
Does Klaris replace our consultants?
No. Klaris automates the line-by-line cross-checking of your Technical Documentation. Your in-house team and your consultants stay focused on strategy, patient-safety judgment, and the calls only a human should make.