Ketryx
AI platform for regulated product development: automated traceability, documentation and FDA/EU MDR compliance.
By Ketryx · 4.2/5 Value-Position score (estimate)
Positioning guardrails
Best for
- MedTech and life-science product teams that must produce FDA, EU MDR and IEC 62304 evidence without slowing engineering.
- Quality and regulatory leaders who need automated traceability between requirements, risks, tests and releases.
- AI-enabled device and diagnostics companies validating models and generating compliant documentation.
- Engineering organisations that want to keep Jira and GitHub while Ketryx orchestrates compliance around them.
Ideal size: 50–1,000+ across R&D, quality and regulatory people · Regulated product company with an established quality/regulatory function and CI-based development.
Not for
- Unregulated SaaS or consumer apps with no submission or audit obligations.
- Teams looking for a full replacement for Jira, GitHub or an eQMS document control system.
- Companies with only a handful of engineers and no quality or regulatory function in house.
- Buyers wanting a low-cost, self-serve compliance checklist tool with published list pricing.
Value metrics scorecard
Time-to-Value
2–4 weeks
~30 days to first production value
Total Cost of Ownership
On request
Free tier for pre-market companies under $2M raised; Startup, Business and Enterprise tiers are quote-based via sales.
Implementation Friction
3/5
Engineering + admin effort required
Value-Position score
out of 5 · model estimate
Full cost breakdown
Mandatory implementation fee
None
Seat tiers
Free: companies under $2M raised; Startup: companies under 200 people; Business and Enterprise: contact sales.
Add-on costs
- None
Company & support
Who is behind Ketryx, and how your team gets help once it is live.
Company
- Founded
- 2021 · 5 yrs in business
- Headquarters
- Not recorded
How you get support
We haven’t recorded support channels for Ketryx yet. Nothing here means unverified — not absent.
Market position
Where Ketryx sits against its closest alternatives. Pick any two of cost, speed, friction and buyer score, and up to 9 companies to compare.
Quadrant view
Typical annual cost × Time-to-value
The lines cross at the median of the solutions shown, so about half sit on each side of each line.
Companies on the chart 6 / 10
- Ketryx
- Censinet
- Clearwater
- Greenlight Guru
- ValGenesis
- MedTrainer
Add or change companies
Up to 10 companies including Ketryx. Listed closest first.
Stack fit signal
Compatibility with standard B2B ecosystems.
No supported MCP path today, so it cannot be driven from an AI client.
AI & MCP readiness
What Ketryx ships in AI, and what it asks of your ecosystem.
AI features shipped
Vendor describes validated AI agents that generate compliant technical documentation, create requirements, suggest traceability links and auto-generate release notes, with humans kept in the loop for safety-critical decisions. No vendor statement was found on which models power it, how AI usage is logged, or how AI is billed.
Your data & models
- Trains on your data
- Not recorded — ask the vendor
- Runs on
- Not recorded
- AI pricing
- Not recorded
In your ecosystem
- AI connection
- Not supported
- Model key
- Not recorded
- AI usage audit
- Not recorded
Compliance attestations
* IAPP AIGP certifies individuals, not products. It means named staff hold the credential — not that the platform does.
Bottom line
Ketryx is an AI compliance and application lifecycle platform for regulated product development, used by four of the top five medical device manufacturers. It sits on top of existing engineering tools, generating traceability, risk records and FDA/EU MDR documentation automatically, with the vendor claiming up to 90% less documentation effort. A free tier serves pre-market startups; paid tiers are quote-based and sold through sales.
Frequently asked questions
Which regulatory frameworks does Ketryx cover?
The pricing page states support for IEC 62304, FDA 21 CFR Part 11, FDA 21 CFR Parts 210, 211 and 820, FDA Cybersecurity Guidance, EU MDR and IVDR, EU GMP Annex 11, GxP, ISO 13485, ISO 9001 and ICH Q10.
How is Ketryx priced?
There is a Free tier for pre-market companies that have raised less than $2 million. Startup (under 200 people), Business and Enterprise tiers require contact with sales. No list prices are published.
Does Ketryx replace Jira, GitHub or our eQMS?
No. Ketryx positions itself as an orchestration layer over existing development tools. Customer quotes describe it updating as engineers work in Jira and GitHub and adding compliance automation around those workflows.
What AI does Ketryx actually ship?
The vendor markets validated agentic AI agents that generate compliant technical documentation, create requirements, suggest traceability links and auto-generate release notes, with humans in the loop for safety-critical decisions.
Is Ketryx SOC 2 compliant?
The pricing FAQ lists 'Is Ketryx SOC 2 Compliant?' but no answer text is published on the pages reviewed, so the certification cannot be confirmed here. Request the current report under NDA.
How long does implementation take?
A customer case study describes migrating a monolithic ecosystem into a single project within days, and the vendor says engagements are backed by its own quality and life-science team. No implementation fee or timeline SLA is published.