Klaris
Klaris is a London-based AI platform that automates regulatory review and cross-document consistency checking of medical-device technical documentation for EU MDR and FDA submissions, using a versioned, expert-validated requirement library to surface traceable gaps and remediation.
- Company typePrivate
- Founded2024
- HeadquartersLondon, United Kingdom
- Headcount1–10
- GTM typeB2B
- OfferingSoftware
What Klaris does
Klaris is a London-based AI software company that automates regulatory compliance review of medical-device technical documentation. The company serves medical-device manufacturers across risk classes that must comply with EU MDR 2017/745 and FDA regulations, addressing a market where roughly 69% of devices are rejected on first FDA 510(k) submission. Klaris' platform runs two integrated AI engines — the Regulatory Reviewer, which checks uploaded documents line-by-line against a versioned library of 1,000+ expert-validated requirements, and the Consistency Reviewer, which cross-checks documents for drift and internal contradictions. Every gap is traceable to the exact clause, paragraph or document reference and ships with drafted remediation guidance, positioning the product as a review and evidence tool rather than a content-generation tool. A specialized ISO 10993-1:2025 Biological Evaluation Review and Remediation module was launched in February 2026 with transparent pricing.\n\nThe business model is SaaS subscription, with general platform pricing gated behind a demo and selective early-adopter access via Google/Microsoft SSO. The go-to-market is sales-assisted direct sales to enterprise MedTech regulatory teams, supplemented by thought-leadership content and an early-adopter program. Initial commercial traction has been established in the UK and Italy, and the February 2026 $1 million pre-seed round led by Meridian Health Ventures is earmarked to scale engineering and product teams and accelerate EU expansion. Trust is a structural part of the offering: Klaris is independently ISO/IEC 27001:2022 certified, GDPR compliant, EU-AI-Act Low-Risk Deployer, and operates a contracted zero data retention policy with LLM providers, with EU data residency in Belgium.
Klaris firmographics
Firmographics- Name
- Klaris
- Legal name
- Klaris AI Ltd.
- Website
- https://klaris.ai
- Company type
- Private
- Founded year
- 2024
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- Klaris is a London-based AI platform that automates regulatory review and cross-document consistency checking of medical-device technical documentation for EU MDR and FDA submissions, using a versioned, expert-validated requirement library to surface traceable gaps and remediation.
- Ownership category
- akta.pro rank
Klaris industry classification
Industry- Product category
- Medical Device Regulatory Compliance Software
- NAICS
- Computer Systems Design and Related Services (5415)
- SIC
- Services-Prepackaged Software (7372)
- akta.pro primary industry
- Computer System Validation (CSV) & GxP IT Compliance (21 CFR Part 11/Annex 11) (HLAGAKAG)
- akta.pro secondary industry
- Quality, Compliance & Validation Software for Labs (GxP/CSV, eQMS for QC Labs) (HLAGAJAI)
Keywords
Where Klaris is headquartered
LocationHeadquarters
- HQ city
- London
- HQ country
- United Kingdom
- HQ region
- Europe
Offices2 records
Markets served
Klaris business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure
Revenue model
- Software Platform Subscription: SaaS platform for automated regulatory review of medical device technical documentation. Users upload documents and receive gap analysis reports with remediation guidance. Revenue likely generated through subscription-based access with pricing based on usage or tier.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Monthly | Biological Evaluation Review and Remediation |
Go-to-market motion2 records
Distribution channels4 records
Marketing channels3 records
Klaris product offering
Product offeringCore offering
Klaris provides a cloud-based AI-powered platform that automates regulatory compliance review of medical device technical documentation. It checks documents line-by-line against an expert-validated library of 1,000+ requirements filtered for device characteristics, identifies gaps with precise clause citations, and surfaces documentation drift across files before submission. The platform is purpose-built for MedTech regulatory workflows including EU MDR 2017/745, FDA submissions, and ISO 10993-1:2025 biological evaluation, delivering structured review reports in hours rather than weeks or months.
Product overview
Klaris offers a unified cloud-based platform for automated regulatory review of medical device technical documentation. The core platform consists of two integrated AI engines: Klaris Regulatory Reviewer (which checks documents against regulatory requirements) and Klaris Consistency Reviewer (which cross-checks documents for internal consistency). Both engines are accessible through the Klaris Platform at run.klaris.ai. The platform also includes specialized sub-products such as the ISO 10993-1:2025 Biological Evaluation Review and Remediation module. Users upload documentation as PDF, DOCX, or XLSX files and receive a structured report with gap citations and remediation guidance within hours.
Differentiator
Problem solved
Functional benefit
Products and services
- Klaris Regulatory Reviewer AI-powered automated regulatory review engine that analyzes medical device technical documentation against expert-validated requirements filtered for device characteristics, identifying compliance gaps with precise clause citations and drafted remediation guidance. Built for regulatory teams at medical device manufacturers preparing EU MDR 2017/745 and FDA submissions.
- Klaris Consistency Reviewer Automated consistency review engine that cross-checks medical device technical documents against each other to detect discrepancies and documentation drift, ensuring clinical claims match intended use and key information remains consistent across all files before submission. Regulation-agnostic and works on any documentation set.
- ISO 10993-1:2025 Biological Evaluation Review and Remediation Specialized review module for biological evaluation documentation against ISO 10993-1:2025, providing clause citations and drafted remediation actions for EU MDR 2017/745 and FDA submissions in hours. Targeted at medical device manufacturers preparing biocompatibility submissions.
- Klaris Platform Cloud-based submission review platform at run.klaris.ai supporting drag-and-drop upload of PDF, DOCX, and XLSX documents with no installation or IT setup required. Hosts both the Regulatory Reviewer and Consistency Reviewer engines and produces structured reports with gap analysis and remediation guidance within hours.
Quantifiable outcome
- 69% of medical devices rejected on first FDA 510(k) submission - Klaris addresses this high rejection rate
- +3 more outcomes
Companies that use Klaris
Customer profileNamed customers5 records
Segments1 record
Ideal customer profiles1 record
Klaris technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability2 records
Feature5 records
Klaris partnerships and signals
Strategic signalScale indicators4 records
Recent moves6 records
Expansion highlights6 records
Klaris competitors and assessment
Company assessmentDirect peers
- Greenlight Guru: Quality management and eQMS platform purpose-built for medical device manufacturers. Comparable target buyer (MedTech regulatory/QA teams) and similar focus on EU MDR/FDA documentation workflows, though Greenlight Guru is broader in scope than Klaris's review specialization.
- Qualio: Cloud eQMS for life sciences companies including MedTech manufacturers. Directly comparable on buyer persona (regulatory/QA leaders at device companies) and EU MDR/FDA documentation workflow focus, though broader than Klaris's review specialization.
- Rimsys: Regulatory information management (RIM) platform specifically for medical device companies, covering submissions, standards tracking, and global registration. Closely comparable target buyer and MedTech-specific scope, with overlapping submission pre-review functionality.
Broad incumbents
- MasterControl: Established QMS and regulatory compliance suite for life sciences manufacturers. Competes for the same regulatory/QA budget as Klaris, with deeper enterprise footprint and a broader product suite spanning documents, training, and audit management.
- Veeva Systems: Dominant cloud platform for life sciences including Vault Quality, Vault Regulatory, and clinical operations. Comparable in addressing MedTech regulatory content management and submissions at large enterprises, with vastly greater scale and breadth.
- ArisGlobal: Life sciences R&D technology vendor with regulatory, safety, and clinical suites. Competes for similar regulatory affairs budgets in MedTech-adjacent pharma/biotech buyers, with broader portfolio but less MedTech-specific depth than Klaris.
- ComplianceQuest: Cloud-native QMS built on Salesforce for MedTech, pharma, and manufacturing. Comparable document control and regulatory compliance focus for medical device manufacturers, with established enterprise deployments.
Emerging players
- RegDesk: AI-driven regulatory intelligence and compliance platform for MedTech and pharma, focused on global regulatory tracking. Comparable AI-for-regulatory positioning, though more intelligence/tracking than pre-submission document review.
- Kivo: Regulatory operations platform for life sciences covering submissions, health authority interactions, and document management. Comparable emerging-stage MedTech/regulatory focus with overlapping pre-submission workflow use cases.
- Dot Compliance: AI-enabled QMS for life sciences and MedTech, including document control and training. Comparable AI-led compliance positioning targeting MedTech manufacturers under EU MDR/FDA, with a similar SaaS go-to-market.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
Klaris social profiles
Digital presenceKlaris compliance and trust
Trust signalCompliance3 records
Klaris financial estimates
Financial estimateRevenue estimate
Valuation estimate
Klaris leadership team
Management profileNumber of profiles
Klaris funding detail
Funding detailFunding overview
Funding rounds2 records
Investors7 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Klaris M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Klaris
What does Klaris do?
Klaris provides a cloud-based AI-powered platform that automates regulatory compliance review of medical device technical documentation. It checks documents line-by-line against an expert-validated library of 1,000+ requirements filtered for device characteristics, identifies gaps with precise clause citations, and surfaces documentation drift across files before submission. The platform is purpose-built for MedTech regulatory workflows including EU MDR 2017/745, FDA submissions, and ISO 10993-1:2025 biological evaluation, delivering structured review reports in hours rather than weeks or months.
Is Klaris a public or private company?
Klaris is a private company. It is classified as venture growth investor backed and is currently operating.
When was Klaris founded?
Klaris was founded in 2024. It employs 1 to 10 people.
Where is Klaris based?
Klaris is headquartered in London, United Kingdom, in the Europe region.
How does Klaris make money?
One revenue line is on record: software Platform Subscription.
Who are Klaris's main competitors?
Direct peers on record are Greenlight Guru, Qualio and Rimsys. Broad incumbents are MasterControl, Veeva Systems, ArisGlobal and ComplianceQuest. Emerging players are RegDesk, Kivo and Dot Compliance.
Does Klaris have an API?
No public API is recorded for Klaris.
What industry is Klaris in?
Klaris's product category is Medical Device Regulatory Compliance Software. Its primary akta.pro industry code is HLAGAKAG, Computer System Validation (CSV) & GxP IT Compliance (21 CFR Part 11/Annex 11), with a secondary code of HLAGAJAI, Quality, Compliance & Validation Software for Labs (GxP/CSV, eQMS for QC Labs). Its NAICS code is 5415 and its SIC code is 7372.