ketryx.com

▸blog139 pages

blog/the-compliance-confidence-trap-what-100-requirements-reviews-still-miss.html

blog/understanding-the-fdas-2026-clinical-decision-support-software-guidance-what-medical-device-companies-need-to-know.html

blog/story-of-ketryx/index.html

blog/we-put-our-own-qms-under-the-microscope-heres-what-we-found.html

blog/understanding-software-as-a-medical-device-samd/index.html

… 134 more pages

▸capabilities16 pages

capabilities/jira-connector/index.html

Ketryx MCP

Ketryx Assistant

capabilities/professional-services/index.html

capabilities/eqms/index.html

▸ai-agents2 pages

capabilities/ai-agents/index.html

AI Agents for Regulated Software Teams

… 9 more pages

▸learn94 pages

Built for Teams Like Yours

learn/index.html

learn/events/index.html

learn/white-papers/index.html

learn/videos/index.html

▸webinars88 pages

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learn/webinars/register/git-for-iec-62304-traceability-for-software-design-unit-testing-and-requirements.html

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▸case-studies14 pages

case-studies/change-impact-ketryx-ai/index.html

How Flo Transitioned from Unregulated to Regulated Development—Without Losing Speed

case-studies/aignostics-case-study/index.html

How Cytovale Transformed Change Impact Assessment with Ketryx AI

Ketryx Announces DeepHealth Selected Its Software to Accelerate AI-Powered Health Informatics Innovation

… 9 more pages

▸gen3 pages

gen/validated-ai-conference/index.html

Validated AI Conference — Cambridge, MA

Validated — San Diego Life Sciences Networking

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▸videos36 pages

New in 2.11: Enhanced Jira Traceability Widget

Unburdening Builders: Reinventing Regulated Development with AI

Streamlining Validation with Ketryx

Anomaly Scoping Agents

Ketryx AI Change Impact Assessment

… 31 more pages

▸events23 pages

Validated AI Conference Half Day

Boston RAPS Chapter In Person Event: Navigating Evolving Global Requirements to Strengthen Regulatory Readiness Worldwide

Health ISAC Spring Americas Summit

Prosthetics & Robtoics

MEDevice Boston

… 18 more pages

▸integrations12 pages

Polarion

Jira

Claude Code

Copilot

SonarQube

… 7 more pages

▸press-release10 pages

Ketryx Enters 2026 with Record Momentum as Demand for Validated AI Surges

Ketryx raises $14M in Series A funding led by Lightspeed Venture Partners

Ketryx Appoints Mary Brook Delano as Chief Business Officer to Accelerate Growth, Sales Execution, and Customer Impact

Ketryx Unveils the First Connected Lifecycle Software for MedTechs

Ketryx Launches Validated AI Conference, a First-of-Its-Kind Industry Event for AI in Regulated Industries

… 5 more pages

▸industries8 pages

Ketryx for Medical Devices

industries/robotics/index.html

industries/defense/index.html

industries/aerospace/index.html

One validated platform, total compliance.

… 3 more pages

▸assets15 pages

A Guide To Implementing CI/CD in Your AI/ML SaMD Projects

FDA Predetermined Change Control Plan (PCCP) Template

IEC 62304 Compliance Checklist

QMS Optimization Workshop Template

SaMD Regulatory Requirements

… 10 more pages

▸white-papers15 pages

Inside the FDA Regulatory Process

FDA PCCP Compliance Guide

SaMD Regulatory Requirements

QMS Optimization Workshop Template

FDA Predetermined Change Control Plan (PCCP) Template

… 10 more pages

▸about6 pages

about/company/index.html

about/newsroom/index.html

Meet the Ketryx Team

Open Positions

About Ketryx

… 1 more pages

▸use-case11 pages

use-case/hw-sw-applications/index.html

Compliance Software for Jira

Software as a Medical Device (SaMD) and Connected Devices

AI for Life Sciences

FDA-Grade AI Compliance in Medical Device Software

… 6 more pages

▸function4 pages

Developer-first tooling for regulated software

AI/ML Leaders in Medical Device Software Development

Build safe, compliant medical device software

AI-Guided Systems Engineering for Safe, Compliant, Connected Development.

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