# Ketryx

**Canonical:** https://apis.io/providers/ketryx/  
**Website:** https://docs.ketryx.com  
**APIs profiled:** 1

Ketryx is an AI-native application lifecycle management (ALM) and compliance platform for regulated medical-device and life-sciences software teams. It integrates with developer tools such as Jira and GitHub to automate the documentation, traceability, and quality-management work required by FDA, EU MDR, ISO 13485, ISO 14971, and IEC 62304, keeping teams continuously audit-ready. Capabilities include automated Design and Development File generation, requirement-risk-code-test traceability, agentic AI for repetitive compliance tasks, ISO 14971 risk management, software bill-of-materials (SBOM) and vulnerability tracking, QMS enforcement, and change-impact assessment. Ketryx exposes a public Build API that lets CI/CD pipelines report builds, JUnit / Cucumber test results, build artifacts, and CycloneDX / SPDX SBOM documents into a project, via a first-party GitHub Action and Python utility. The company is backed by Lightspeed Venture Partners.

## Kin Score — 35.2 / 100 (thin)

Scored 2026-08-30 under rubric 0.17.2. Trend: flat (+0.0 from 35.2).

| Facet | Score |
|---|---|
| Discoverability | 75.9 |
| Contract Quality | 14.3 |
| Governance | 18.2 |
| Contract Governance | 18.2 |
| Operational Transparency | 2.6 |
| Developer Ergonomics | 28.0 |
| Commercial Clarity | 60.5 |
| Access Clarity | 60.5 |

Regulatory layer — **Health**: 43.8 (matched via tags).

## Agent readiness — 21.0 (agent-aware)

| Dimension | Value |
|---|---|
| Spec Presence | yes |
| Agentic Access | derived |
| Reversibility Documented | no |
| MCP Server | no |
| Auth Clarity | bearer |
| Idempotency | no |
| Error Semantics | documented |
| OpenAPI Examples | no |
| Rate Limit Signal | no |
| Event Surface Described | no |
| Agent Skills | derived |
| Well Known Catalog | no |
| Consent Identity | no |
| Agent Card | no |
| Dry Run Mode | no |
| Delegated Identity | no |
| Protected Resource Metadata | no |
| Dynamic Client Registration | no |
| Agentic Commerce | no |

## Access

Self-serve signup — onboarding: self-serve, pricing: unknown, trial: no (confidence: medium).

## APIs (2)

- **Ketryx Artifacts API** — Upload build artifacts, test results, and SBOM files.
- **Ketryx Builds API** — Report builds and their status to Ketryx.

## MCP servers (1)

- **Ketryx MCP Server**

## Agentic access (1)

- **Ketryx Agentic Access** — 2 operations · 2 acting

## Security (3)

- **Ketryx Authentication** — http · 1 scheme
- **Ketryx Domain Security** — TLSv1.3 · DMARC
- **Ketryx Trust Center** — SOC 2 Type 2, SOC 3, ISO/IEC 27001:2022, ISO 13485:2016, ISO 14971:2019, IEC 62304:2006, HIPAA BAA, FDA 21 CFR Part 11

## Tags

Company, Medical Devices, Life Sciences, Compliance, Regulatory, Application Lifecycle Management, Quality Management, SBOM, DevOps, Healthcare, Governance, CI/CD

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Profiled by [API Evangelist](https://apievangelist.com) and published on [APIs.io](https://apis.io/providers/ketryx/). Scores are computed from the provider's own public artifacts under a published rubric.