Ketryx
Ketryx is an AI-native compliance platform founded in 2021 that connects developer tools into a unified traceability and documentation system for regulated product teams. It serves medical device manufacturers and adjacent safety-critical industries, with four of the top five Fortune 500 MedTech companies on the platform.
- Company typePrivate
- Founded2021
- HeadquartersCambridge, United States
- Headcount51–100
- GTM typeB2B
- OfferingSoftware
What Ketryx does
Ketryx is an AI-native compliance platform for safety-critical product development, founded in 2021 and headquartered in Cambridge, Massachusetts with a European office in Vienna, Austria. The company operates an overlay architecture that connects existing developer tools — Jira, GitHub, GitLab, Azure DevOps, and Polarion — into a unified knowledge graph that maintains real-time requirements traceability, automates documentation generation, and enforces Quality Management System procedures across the software development lifecycle. Core capabilities include validated AI Agents (for coding, change impact assessment, regression testing, and anomaly scoping), an MCP server delivering live compliance context to ChatGPT, Claude, and Copilot, SBOM management, eQMS, and modules covering IEC 62304, EU Cyber Resilience Act, and EU AI Act compliance. The platform is UL-certified to IEC 62304, ISO 13485, and ISO 14971, and holds SOC 2 Type 2, ISO/IEC 27001, and HIPAA compliance.
The company serves regulated industries with a primary focus on medical device manufacturers, including Medtronic, Meta Reality Labs, HeartFlow, Flo Health, RadNet, and Cytovale, alongside expansion into pharmaceutical, robotics, automotive, aerospace, defense, and nuclear safety verticals. Four of the top five Fortune 500 MedTech manufacturers run on the platform, and Ketryx-powered products reach over 100 million patients as of February 2026.
Ketryx monetizes primarily through enterprise SaaS subscriptions on annual or multi-year terms with quote-based pricing, complemented by a 30-day free trial that supports a self-serve product-led growth motion. The go-to-market combines direct enterprise field sales targeting Fortune 500 MedTech and life sciences companies with proof-of-concept evaluations, alongside a freemium tier and partner reseller channels. Total funding raised exceeds $55 million across seed, Series A (Lightspeed, December 2023), and Series B (Transformation Capital, September 2025) rounds.
Ketryx firmographics
Firmographics- Name
- Ketryx
- Legal name
- Ketryx Corporation
- Website
- https://ketryx.com
- Company type
- Private
- Founded year
- 2021
- Operating status
- Operating
- Headcount range
- 51–100 employees
- Short description
- Ketryx is an AI-native compliance platform founded in 2021 that connects developer tools into a unified traceability and documentation system for regulated product teams. It serves medical device manufacturers and adjacent safety-critical industries, with four of the top five Fortune 500 MedTech companies on the platform.
- Ownership category
- akta.pro rank
Ketryx industry classification
Industry- Product category
- Regulatory Compliance Software for Life Sciences
- NAICS
- Testing Laboratories and Services (54138), Other Scientific and Technical Consulting Services (54169)
- akta.pro primary industry
- Quality Engineering & Risk Management (ICH Q9/Q10, validation, change control) (HLAGAKAL)
Keywords
Where Ketryx is headquartered
LocationHeadquarters
- HQ city
- Cambridge
- HQ country
- United States
- HQ region
- North America
Offices3 records
Markets served
Ketryx business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Personnel, Technology or R&D, Marketing or Sales, Operations, Infrastructure
Revenue model
- Software Subscription (SaaS): Annual or multi-year subscription-based access to Ketryx Platform with varying tiers based on organization size and feature requirements. Includes support services, maintenance, and regular updates.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Freemium | Pay-as-you-go | Free Trial Tier |
Go-to-market motion3 records
Distribution channels3 records
Marketing channels10 records
Ketryx product offering
Product offeringCore offering
Ketryx is an AI-native connected lifecycle management platform that automates documentation, traceability, and compliance workflows for regulated product teams, primarily in life sciences and medical device manufacturing. The platform overlays existing development tools (Jira, GitHub, GitLab) to deliver real-time requirements traceability, automated FDA-compliant documentation (Design History Files, 510(k) submissions), eQMS enforcement, SBOM management, and validated AI agents with human-in-the-loop controls. The platform supports compliance with FDA, EU MDR, IEC 62304, ISO 13485, ISO 14971, and EU AI Act / Cyber Resilience Act standards.
Product overview
Ketryx is an AI-native compliance platform for safety-critical product development in life sciences. The platform operates as a unified overlay system that connects existing development tools (Jira, GitHub, GitLab) into a single traceable software development lifecycle. Core offerings include the Ketryx Platform, AI Agents (validated agents for automating compliance tasks), Traceability (real-time requirements matrix), Documentation (auto-generated FDA-compliant files), SBOM Management, Requirements Management, Risk Management, Enforcement (QMS enforcement), eQMS, AI Assistant, and Model Context Protocol (MCP) for AI tool integration. Additional modules cover Jira for 62304 compliance, EU CRA compliance, and EU AI Act compliance. The platform is UL-certified under ISO 13485 and supports medical device, pharmaceutical, robotics, automotive, aerospace, defense, and nuclear industries.
Differentiator
Problem solved
Functional benefit
Products and services
- Ketryx Platform AI-native connected lifecycle management SaaS platform for life sciences that automates documentation, traceability, and QMS enforcement for regulated product teams. The platform overlays existing development tools (Jira, GitHub, GitLab, Polarion) to deliver real-time requirements traceability, automated FDA-compliant documentation (Design History Files, 510(k) submissions), eQMS, SBOM management, risk management, and AI-driven change impact assessment. The platform is UL-certified to IEC 62304, ISO 13485, and ISO 14971, and is SOC 2 Type 2, ISO/IEC 27001, and HIPAA compliant.
- AI SDLC Transformation Professional Services Expert-led professional services engagement that helps regulated organizations accelerate AI maturity and transform their software development lifecycle for AI-enabled medical products, delivered by Ketryx's regulatory and engineering experts.
Quantifiable outcome
- Reduces documentation burden by up to 90%
- +7 more outcomes
Companies that use Ketryx
Customer profileNamed customers13 records
Segments8 records
Ideal customer profiles3 records
Ketryx technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- Yes
- API docs
- API detail
Core technology
AI maturity
App detail
Integration7 records
AI capability8 records
Feature9 records
Ketryx partnerships and signals
Strategic signalPartnerships
Four partnerships are on record, tiered minor and core.
- XtalksminorPartner hosting free webinar on PCCPs and CI/CD for medical devices featuring Ketryx speakers. Webinar scheduled for April 2, 2026.
- UL SolutionscoreCertification partner for IEC 62304, ISO 13485, and ISO 14971 standards. UL Solutions provides third-party certification of Ketryx's quality management system.
- OpenAIcoreAI technology vendor providing language models for Ketryx's AI tools. Ketryx uses OpenAI via zero data retention endpoints to ensure customer data is not used for training.
- SensibacoreThird-party auditor providing SOC 2 Type 2 and ISO/IEC 27001 certification services.
Scale indicators9 records
Recent moves6 records
Expansion highlights6 records
Ketryx competitors and assessment
Company assessmentBroad incumbents
- Veeva Systems: Veeva is the dominant cloud software platform for life sciences, offering Vault QMS, Vault RIM, and validated applications across pharma and MedTech. It overlaps with Ketryx in regulated content management, validation, and submissions for life sciences customers, though it is far broader in scope and serves as a potential partner/competitor rather than a head-to-head niche rival.
- Siemens Polarion: Siemens Polarion is an ALM and requirements management platform with deep use in regulated industries including medical devices, automotive, and aerospace. It is both a potential competitor for Ketryx's Traceability offering and an integration partner (Ketryx explicitly supports Polarion interoperability), representing the incumbent ALM standard that Ketryx positions against.
- Aras Innovator: Aras provides a next-generation PLM platform with regulated industry use cases including medical devices and complex systems engineering. It competes for the same digital thread and connected lifecycle narrative that Ketryx sells, but as a broader, configurable PLM suite rather than an AI-native overlay.
Direct peers
- Benchling: Benchling is a cloud R&D platform for biotech with strong traction in life sciences informatics and validated workflows. While Benchling centers on wet-lab R&D and Benchling's own data model, both companies compete for the same regulated life sciences IT budget, and Benchling's success in biopharma sets a comparable benchmark for cloud-native, validated life sciences software.
- MasterControl: MasterControl provides QMS, document control, CAPA, and compliance software purpose-built for life sciences and medical device manufacturers. It is a direct competitor in the MedTech QMS / eQMS space that Ketryx's eQMS and Enforcement modules target, though MasterControl is a more established, on-prem-leaning incumbent.
- Greenlight Guru: Greenlight Guru is an eQMS and quality management platform built specifically for medical device companies, covering design controls, DHF, risk management, and CAPA. It is a direct competitor for the same MedTech QMS budget that Ketryx addresses, with a more established installed base but less AI-native automation.
- Qualio: Qualio offers cloud-native eQMS software for life sciences companies, with a strong focus on medical device and pharma quality teams. It is a direct peer in the MedTech QMS category, comparable in target customer profile and SaaS delivery model, though typically serving smaller customers than Ketryx's enterprise MedTech base.
- Jama Software: Jama Software provides requirements management and traceability tools widely used in medical device, automotive, and aerospace development. It directly competes with Ketryx's Traceability and Requirements Management capabilities, especially for teams standardizing on Jama Connect for IEC 62304 and ISO 26262 workflows.
- AssurX: AssurX provides configurable QMS, document control, and compliance workflow software for regulated industries including medical devices and pharmaceuticals. It is a long-standing QMS vendor competing for the same MedTech eQMS budget that Ketryx's Enforcement and eQMS capabilities target.
Emerging players
- Dot Compliance: Dot Compliance delivers AI-enabled QMS and regulatory compliance solutions for life sciences, including medical device manufacturers. It overlaps with Ketryx's eQMS and AI Change Impact capabilities, representing a more recent entrant applying AI to compliance in the same target market.
Market position
Competitive moat5 records
Key risks5 records
Key highlights6 records
Customer concentration
Ketryx social profiles
Digital presenceKetryx compliance and trust
Trust signalCompliance6 records
Ketryx financial estimates
Financial estimateRevenue estimate
Valuation estimate
Ketryx leadership team
Management profileNumber of profiles
Profiles8 records
Ketryx funding detail
Funding detailFunding overview
Funding rounds4 records
Investors5 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Ketryx 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 Ketryx
What does Ketryx do?
Ketryx is an AI-native connected lifecycle management platform that automates documentation, traceability, and compliance workflows for regulated product teams, primarily in life sciences and medical device manufacturing. The platform overlays existing development tools (Jira, GitHub, GitLab) to deliver real-time requirements traceability, automated FDA-compliant documentation (Design History Files, 510(k) submissions), eQMS enforcement, SBOM management, and validated AI agents with human-in-the-loop controls. The platform supports compliance with FDA, EU MDR, IEC 62304, ISO 13485, ISO 14971, and EU AI Act / Cyber Resilience Act standards.
Is Ketryx a public or private company?
Ketryx is a private company. It is classified as venture growth investor backed and is currently operating.
When was Ketryx founded?
Ketryx was founded in 2021. It employs 51 to 100 people.
Where is Ketryx based?
Ketryx is headquartered in Cambridge, United States, in the North America region.
How does Ketryx make money?
One revenue line is on record: software Subscription (SaaS).
Who are Ketryx's main competitors?
Broad incumbents on record are Veeva Systems, Siemens Polarion and Aras Innovator. Direct peers are Benchling, MasterControl, Greenlight Guru, Qualio, Jama Software and AssurX. Dot Compliance is listed as an emerging player.
Does Ketryx have an API?
Yes. Ketryx offers a Model Context Protocol (MCP) server that enables AI tools such as ChatGPT, Claude, and Copilot to securely access live compliance data. The MCP integrates fragmented product lifecycle management, application lifecycle management, and development tools into a unified knowledge graph. The company also provides developer documentation at docs.ketryx.com for integration purposes. Developer documentation is at docs.ketryx.com.
What industry is Ketryx in?
Ketryx's product category is Regulatory Compliance Software for Life Sciences. Its primary akta.pro industry code is HLAGAKAL, Quality Engineering & Risk Management (ICH Q9/Q10, validation, change control). Its NAICS code is 54138.