Snapshot
Continue to About ↓- What it does
- Ketryx is a web-based, AI-native compliance platform for teams building regulated, safety-critical products such as medical devices, SaMD, pharma and hardware-software systems.
More detail
- It overlays existing development tools like Jira and GitHub with automated traceability, AI-assisted documentation and QMS enforcement so compliance evidence is generated as teams build.
- Best for
- Regulated product teams (medical device, SaMD, pharma/GxP, robotics, automotive, aerospace) whose engineers already work in Jira, GitHub and similar tools and need continuous traceability and audit-ready documentation.
- Pricing
- Annual subscription, structured by number of users and features according to an independent review
More detail
- exact per-seat rates for the Startup, Business and Enterprise tiers are not disclosed and require contacting sales.
- A Free tier ($0/year) exists but is restricted to pre-market companies that have rai
- Main limitation
- Unregulated software teams, or organizations wanting a fully autonomous compliance system without qualified regulatory staff in the loop.
More detail
- Also a poor fit for pre-market companies that have raised more than US$2M but cannot engage a sales-led commercial contract.
- Record
- Living and monitored
- Reviewed
- Evidence
- Public web research
- Machine access
- Structured profile ↗
About
- Ketryx is a web-based, AI-native compliance platform for teams building regulated, safety-critical products such as medical devices, SaMD, pharma and hardware-software systems.
- It overlays existing development tools like Jira and GitHub with automated traceability, AI-assisted documentation and QMS enforcement so compliance evidence is generated as teams build.
What it helps with
- Traceability across disconnected engineering and documentation tools lags behind development work
- Document-gated control points stall release cycles between development completion and formal testing
- Compliance evidence is collected outside engineering tools, forcing separate systems
- Manual assembly of release and submission documentation (e.g., Design and Development Files, 510(k) artifacts) is slow
- Quality management system procedures are hard to enforce consistently across the product lifecycle
- SBOM and vulnerability obligations (e.g., EU CRA) are difficult to maintain from existing toolchains
- AI and regulatory changes are hard to assess for impact across design and development files
- Keeping products audit-ready continuously rather than at audit time
Capabilities
A practical view of what is available and where limitations apply.
| Offering | Available | Detail |
|---|---|---|
| Automated traceability | Yes | Traces requirements, risks, code and tests; links Git automated tests to Jira requirements |
| AI-generated documentation | Yes | Vendor states AI compiles submission-ready Design and Development Files and drafts documentation; 'up to 90%' documentation reduction is a vendor claim, not independently verified |
| AI Agents with human review | Yes | Drafts documentation, proposes traceability links and performs change-impact analysis; explicitly keeps humans in the loop |
| Risk management | Yes | Vendor states risks are controlled and documented in an ISO 14971-aligned way |
| eQMS / QMS enforcement | Yes | Enforces SOPs and flags deviations inside connected tools |
| SBOM management | Yes | Software supply chain tracking from SBOM to release, framed around EU CRA obligations |
| Existing toolchain integrations | Yes | Jira, GitHub, GitLab, AWS, Jama, TestRail, Polarion; IDE/LLM context via MCP |
| Fully autonomous compliance without human review | No | Product is designed around human-in-the-loop review, not replacement of regulatory staff |
| Public per-seat pricing | No | Only a restricted Free tier is published; commercial tiers require contacting sales |
| On-premises deployment | Unknown | Terms describe the platform as a web-based application; no on-prem option stated in sources reviewed |
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Evidence
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- Verification
- Scribble researched these facts from the linked public sources.
- The owner has not manually confirmed every field.
- Last reviewed
- Primary source
- ketryx.com
Technical profile details
Record ID
72250e84-8778-473c-b31a-d39fd6638786Canonical URLhttps://profiles.scribble.network/listing/ketryx-72250e84