Tool profile
Ketryx: cost, fit and limits
Ketryx is a compliance and lifecycle platform made by Ketryx Corporation that connects requirements, risks, code and tests for teams building regulated medical device and other safety-related software, with AI agents and an assistant. It connects to tools such as Jira and Git rather than replacing them.
What to know first
Ketryx has four tiers. Free costs $0 per year but only for pre-market companies that have raised less than $2 million, while Startup, Business and Enterprise are quoted by sales. The platform leans on Jira and Git, compiles a submission-ready Design and Development File and handles risk control and SBOM management. Its AI layer covers agents, an assistant and change impact assessment.
Ketryx at a glance
| Maker | Ketryx Corporation, Not stated by the vendor |
|---|---|
| Free plan | Yes |
| Entry price | $0 per year (Free plan) |
| API access | No |
| Category | Best AI Requirements Management Software in 2026, rank 5 of 10 |
| Website | ketryx.com |
Who Ketryx is best for
Pre-market medical device startups
The free plan is limited to companies under $2 million in funding, so a seed-stage team can build a validated system before it pays anything.
Jira teams chasing IEC 62304
A Jira-based option supports IEC 62304 and EU CRA work, with automated tests held in Git traced to requirements stored in Jira.
Companies preparing FDA or MDR files
The platform compiles a submission-ready Design and Development File and keeps risk management in a 14971-compliant way, saving manual assembly of evidence.
Ketryx plans and pricing
| Plan | Price | What it includes |
|---|---|---|
| Free | $0 per year | For pre-market companies starting to build validated systems that have raised less than $2 million in funding. |
| Startup | Custom quote (contact sales) | Aimed at startups and growing companies; the pricing page lists no limits or amounts. Startup includes no stated limits. |
| Business | Custom quote (contact sales) | For scaling companies looking to accelerate their product lifecycle; no amounts or feature lists are shown. |
| Enterprise | Custom quote (contact sales) | For established companies streamlining processes across the product lifecycle; sold as a subscription varying by size, stage and products. |
Checked November 2026.
What Ketryx does
- Ketryx AI agents
- AI Agents automate tasks while keeping humans in the loop, and an AI Assistant generates artifacts and answers questions from project context. The vendor describes both as keeping a person in the loop for decisions.
- AI change impact assessment
- Assesses how a change spreads across the Design and Development File, so reviewers see affected requirements, risks and tests early. Seeing affected requirements, risks and tests early can shorten a review cycle.
- Traceability across tools
- Links requirements, risks, code and tests, tracing automated tests in Git back to requirements held in Jira. That connection lets developers keep working in their normal tools while records build up.
- SBOM management
- Handles the software bill of materials from first listing to release, which matters for products that must document third-party components. Teams must document third-party components for regulators, and this feature keeps that list current.
- Ketryx MCP
- Provides compliance context inside IDEs and large language model clients, so developers can check requirements while coding. Developers can check compliance context from their editor rather than switching to a separate portal.
How Ketryx handles your data
The vendor's policy was not checked for training use, retention or hosting region: the privacy policy page returned 404 when opened, and the homepage states none of these. The homepage links to a Certifications page that was not read, and it lists no certificate itself. Industry sections describe development as aligned with FDA, MDR and ISO 13485 requirements, which describes the intended use of the product and not a certificate held by Ketryx. Ask for the trust documentation before uploading design files.
Where Ketryx falls short in practice
- Free plan eligibility is narrow. Only pre-market companies with under $2 million raised qualify, so a team that crosses that line moves to a quote-only tier. Growing teams must plan for a quote-only tier.
- Paid prices are hidden. Startup, Business and Enterprise are all quoted, and the FAQ only says options vary by company size, stage and products. Buyers cannot compare cost against listed prices of other tools.
- Regulated focus. The page targets medical devices, pharma, automotive, aerospace and defense, so a plain web product team would pay for compliance structure it does not use.
- Jira-centered setup. IEC 62304 support is described for the Jira-based option, with Git and GitHub alongside it, so teams on other trackers get less guidance. Teams on other trackers get less guidance in the pages read.
Works with
Alternatives to Ketryx
Ketryx: common questions
Who qualifies for the Ketryx free plan?
The pricing page lists Free at $0 per year for pre-market companies that are starting to build validated systems and have raised less than $2 million in funding. Companies beyond that threshold would use Startup, Business or Enterprise, all of which are priced through a sales conversation.
What AI does Ketryx include?
Ketryx AI has AI Agents that automate tasks while keeping humans in the loop, an AI Assistant that generates artifacts and answers questions from project context, and AI Change Impact Assessment across the Design and Development File. Which tier includes which feature was not stated on the pages read.
Does Ketryx replace Jira?
No. The platform builds on Jira and Git rather than replacing them: it traces automated tests in Git to requirements in Jira and offers a Jira-based option for IEC 62304 and EU CRA support. Teams keep their tracker and add compliance records on top.
Can Ketryx help with an SBOM?
Yes. The page lists SBOM management from the software bill of materials through release, and a Jira-based option that supports IEC 62304 and EU CRA work covering 10-year technical files. Detail on formats and scanning sources was not given on the pages read.
Is Ketryx data stored in Europe?
The pages read do not name a hosting region, and the privacy policy page returned 404 when opened. A buyer with European residency needs should ask the vendor for hosting locations and subprocessors in writing, as nothing on the pages checked answers that question.