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RegScale
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What is Ketryx?
Founded in 2021 and headquartered in Cambridge, Massachusetts, Ketryx provides connected lifecycle management for regulated software and medical-device teams. It has raised more than $55 million and serves medical-device manufacturers and life-science companies.
Ketryx is an AI-native connected lifecycle-management platform for regulated product development. It overlays tools such as Jira, GitHub, GitLab, AWS and Polarion, connecting requirements, risks, tests, approvals and release evidence. AI agents analyze work in those systems, suggest traceability links, identify gaps, draft compliance documentation and support change-impact analysis. The platform creates a continuously updated record of how a product was specified, built, verified and released.
The platform covers requirements management, risk management, traceability, verification and validation, quality-management workflows, release documentation, postmarket surveillance and software-bill-of-materials generation. Its published coverage includes IEC 62304, ISO 13485, ISO 14971, FDA 21 CFR Part 11, FDA cybersecurity guidance, EU MDR and IVDR, GxP, ISO 9001, ICH Q10 and FDA 21 CFR Parts 210, 211 and 820. Ketryx is strongest for software-centered regulated products; broader quality-system requirements require separate scoping.
Ketryx sells to medical-device, diagnostics, pharmaceutical, biotech and other safety-critical product teams, from startups to enterprises. Paid Startup, Business and Enterprise plans are quote-based, while the Free plan is available to pre-market companies that have raised less than $2 million. AWS Marketplace also lists the product as free of charge, with possible AWS infrastructure costs. Complex environments should budget for implementation and validation work rather than a simple self-serve purchase.
Key features
Requirements management
Manage requirements in connected development workflows with revision control, approvals and regulatory context.
AI traceability
Map requirements, risks and tests, detect gaps and suggest missing links across connected tools.
Risk management
Capture and connect product risks, controls and verification evidence for regulated development records.
Quality workflows
Enforce QMS processes for changes, CAPAs, anomalies, complaints and approvals inside existing developer tooling.
Validation documentation
Generate Part 11-oriented evidence and lifecycle documents, with exports to Word, Excel and PDF.
SBOM and cybersecurity
Generate FDA-ready software bills of materials and support cybersecurity documentation for regulated releases.
Release intelligence
Automate release notes, change-impact analysis and postmarket-surveillance work while keeping humans in control.
Ketryx pricing
Ketryx lists Free, Startup, Business and Enterprise plans. The Free plan costs $0 per year for qualifying pre-market companies, while paid-plan pricing is not published. AWS Marketplace lists Ketryx as free of charge, with additional AWS infrastructure costs potentially applying.
| Plan | Price | What's included |
|---|---|---|
| Free | $0/yearPre-market companies with less than $2 million raised | Validated-system starting point for pre-market companies |
| Startup | CustomCompanies under 200 people | Connected lifecycle management for growing teams |
| Business | Custom | Lifecycle management for scaling software-development organizations |
| Enterprise | Custom | Lifecycle management for established organizations across the software lifecycle |
Free trial: A free plan is available to pre-market companies that have raised less than $2 million; paid plans require a sales conversation.
Pros & cons
Pros
- Connects compliance evidence to the developer tools regulated teams already use.
- AI agents can suggest traceability links, draft documentation and flag compliance gaps.
- Published framework coverage spans major medical-device and life-science standards.
- The free qualifying plan gives pre-market startups a no-cost entry point.
Cons
- Paid pricing is quote-only, so buyers cannot compare subscription costs online.
- Public independent review volume is very small.
- Some configuration requires JSON editing, according to an AWS Marketplace review.
- The platform is centered on software and connected workflows rather than every traditional eQMS use case.
Who is Ketryx best for?
- Medical-device software teams that need traceability across Jira-based development.
- Regulated product organizations automating FDA and EU MDR documentation.
- Life-science startups seeking a qualifying free plan before commercialization.
- Enterprise medtech teams connecting existing engineering and quality tools.
Frameworks and coverage
Integrations
Notable customers
Frequently asked questions
How much does Ketryx cost?
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Ketryx lists a $0-per-year Free plan for qualifying pre-market companies that have raised less than $2 million. Startup, Business and Enterprise plans are quote-based; AWS Marketplace also lists a free subscription, with possible AWS infrastructure costs.
How long does Ketryx take to implement?
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Ketryx does not publish a standard implementation timeline. Public customer material describes one team establishing an IEC 62304 process and passing an audit within three months, but timing depends on scope, integrations and validation requirements.
How does Ketryx compare with Vanta?
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Ketryx is designed around regulated product development, linking requirements, risks, tests, releases and medical-device evidence in engineering tools. Vanta is primarily an automated security and compliance platform for company-level frameworks, so the products address different compliance needs.
Which integrations does Ketryx support?
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Published integrations include Jira, GitHub, GitLab, AWS, Polarion, Jama, TestRail and Azure DevOps. Ketryx also supports exporting documentation to Word, Excel and PDF.
Who should buy Ketryx?
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Ketryx is aimed at medical-device, diagnostics, pharmaceutical, biotech and other regulated product teams. It is particularly relevant where engineering teams need continuous traceability and audit evidence without abandoning existing developer tools.
Is Ketryx secure and accurate for regulated work?
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Ketryx's trust center lists SOC 2 Type 2, SOC 3, ISO/IEC 27001:2022, ISO 13485:2016, ISO 14971:2019 and IEC 62304 materials. Its AI agents assist with documentation and traceability, while regulated organizations remain responsible for reviewing, validating and approving generated evidence.
Sources
Facts and pricing verified on October 19, 2026. Vendors change pricing often, so confirm with Ketryx before buying. How we research
