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Product

What is Ketryx?

AI-native compliance for regulated medical applications

AI/ML in Medical Devices

Rapidly accelerate AI/ML software development and deployment, while staying compliant.

SaMD and Connected Devices

Reduce the complexity, time, and cost of building SaMD (Software as a Medical Device) applications.

Transform Jira into a validated, compliant platform for medical device development.

System of Systems

Accelerate development and reuse components through a system of systems architecture.

AI Governance for Life Sciences

Reduce the complexity, time, and cost of GxP validation for your application.

Traceability to Automated Tests

Automatically trace automated tests in Git to requirements in Jira.

Multifunction Devices

Release device and non-device functions independently with a system of systems architecture.

Hardware-Software Products

Unify compliance and accelerate development across mechanical, electrical, and software teams

Watch a short recorded demo

Automate arduous tasks across your toolchain with safety-critical AI agents that keep a human in the loop.

Compliance in your AI Tools

Real-time compliance context embedded directly into your IDE and LLM via MCP

SBOM Management

See a single consolidated view of your open-source supply chain directly from your source code.

Automatically create a real-time requirements traceability matrix by connecting items, risks, code, and tests from all your systems.

Automatically compile all requirements, design inputs, outputs, and tests into a configurable and submission-ready Design and Development File.

Enforce your QMS to ensure your team is following SOPs exactly as you've defined them.

AI SDLC Transformation

Accelerate your AI maturity, guided by our experts

Requirements Management

Manage and trace requirements across connected systems like Jira.

Risk Management

Control and document every risk automatically in a 14971-compliant way.

Navigate compliance confidently with an eQMS that's interoperable with all your favorite tools.

AI Change Impact Assessment

Apply AI to automate change impacts across your Design and Development File, reducing manual effort and increasing trust.

Generate compliant artifacts, analyze traceability, and answer QMS questions using your real project context.

Comply with EU CRA

Meet EU Cyber Resilience Act obligations for SBOMs, vulnerability reporting, and 10-year technical files using your existing toolchain

Enforce your QMS procedures, prevent process deviation, and ensure your software is audit-ready 100% of the time throughout the SDLC.

Keep your developers working in their preferred DevTools while maintaining compliance and traceability.

Reduce your documentation burden by 90% and release your AI products faster.

Systems Engineering

Manage architecture and monitor change impact across the total product lifecycle

Watch a short recorded demo

What is Ketryx?

AI-native compliance for regulated medical applications

Use Cases

AI/ML in Medical Devices

Rapidly accelerate AI/ML software development and deployment, while staying compliant.

SaMD and Connected Devices

Reduce the complexity, time, and cost of building SaMD (Software as a Medical Device) applications.

Transform Jira into a validated, compliant platform for medical device development.

System of Systems

Accelerate development and reuse components through a system of systems architecture.

AI Governance for Life Sciences

Reduce the complexity, time, and cost of GxP validation for your application.

Traceability to Automated Tests

Automatically trace automated tests in Git to requirements in Jira.

Multifunction Devices

Release device and non-device functions independently with a system of systems architecture.

Hardware-Software Products

Unify compliance and accelerate development across mechanical, electrical, and software teams

Watch a short recorded demo

Capabilities

Automate arduous tasks across your toolchain with safety-critical AI agents that keep a human in the loop.

Compliance in your AI Tools

Real-time compliance context embedded directly into your IDE and LLM via MCP

SBOM Management

See a single consolidated view of your open-source supply chain directly from your source code.

Automatically create a real-time requirements traceability matrix by connecting items, risks, code, and tests from all your systems.

Automatically compile all requirements, design inputs, outputs, and tests into a configurable and submission-ready Design and Development File.

Enforce your QMS to ensure your team is following SOPs exactly as you've defined them.

AI SDLC Transformation

Accelerate your AI maturity, guided by our experts

Requirements Management

Manage and trace requirements across connected systems like Jira.

Risk Management

Control and document every risk automatically in a 14971-compliant way.

Navigate compliance confidently with an eQMS that's interoperable with all your favorite tools.

AI Change Impact Assessment

Apply AI to automate change impacts across your Design and Development File, reducing manual effort and increasing trust.

Generate compliant artifacts, analyze traceability, and answer QMS questions using your real project context.

Comply with EU CRA

Meet EU Cyber Resilience Act obligations for SBOMs, vulnerability reporting, and 10-year technical files using your existing toolchain

Function

Enforce your QMS procedures, prevent process deviation, and ensure your software is audit-ready 100% of the time throughout the SDLC.

Keep your developers working in their preferred DevTools while maintaining compliance and traceability.

Reduce your documentation burden by 90% and release your AI products faster.

Systems Engineering

Manage architecture and monitor change impact across the total product lifecycle

Watch a short recorded demo

Case Studies

Learn how Meta Reality Labs builds regulated medical products without sacrificing engineering velocity.

See how Flo Health, with 430M users, transitioned to regulated development in just 90 days

Learn how AI-powered radiology company DeepHealth accelerated product development with Ketryx

How This AI-Powered Medical Software Company Reduced SBOM Documentation Time by 90%

Discover how AI/ML-enabled cardiovascular MedTech company HeartFlow reduced complexity by 90% with a system of systems

Learn how an AI-driven diagnostics company transformed change impact assessment

Learn how Beacon Biosignals reduced their release cycle to two weeks for AI/ML products

Learn how a Top 5 MedTech company assessed vulnerabilities 80% faster

Discover how AI pathology company Aignostics stopped copying and pasting and accelerated their release cycle time

Explore how Foresight Diagnostics accelerated their documentation cycle by 5x

See how AI-enabled cardiovascular MedTech company Vektor Medical reduced documentation cycle time by 60%

Learn how an Enterprise IVD company accelerated end-to-end release cycles by 85%

“Ketryx AI is the most scalable approach we’ve used for regulated product development. It lets our teams make frequent, safe changes while staying continuously audit-ready, without relying on linear headcount growth or stopping teams for compliance exercises.”

Lucas Fernandez

Director of Medical Devices

"Ketryx gave us a scalable way to manage product cybersecurity risk. We’re running assessments more frequently, prioritizing the right issues, and improving our overall security posture without increasing effort."

Director of Product Security

"Delivering quickly is core to our mission because faster releases mean better health outcomes for our users. Ketryx is the only partner we found that gave us the ability to maintain our velocity while achieving medical-grade quality.”

Roman Bugaev

CTO

“We’re excited about how Ketryx helps us improve our overall pace of release. With Ketryx’s AI, we’ve transformed our multi-week manual process of change impact analysis into less than an hour.”

CTO

“The Ketryx software enables us to scale our innovation with quality through a single streamlined software development lifecycle, helping us expedite releases.”

Sham Sokka

Chief Operating and Technology Officer for Digital Health

"Ketryx is becoming an intrinsic part of every piece of software we build. It’s not another tool we have to use on the side to be compliant with standards; it’s just a natural way of developing high-quality software with excellence."

Helmut Hoffer von Ankershoffen

Senior VP Product and Engineering

"Vektor Medical has been through three audits, including one from a leading notified body in 2024. All auditors were amazed by the level of detail, linkage and control that is built into Ketryx. The auditors were especially impressed by the trace matrix dashboard and risk management module. Ketryx is an efficient and compliant solution for medical device software development."

Mihir Naik

Senior Director, Quality

“Ketryx empowered Nutrino to accelerate the adoption of OTS software and SOUP, ensuring confidence in our ability to proactively identify high-risk components and address potential issues early in the premarket submission cycle. This streamlined SDLC process has enabled us to deliver innovative and safe diabetes solutions much more rapidly.”

Chen Weitz

Senior Engineering Director

"I used a traditional ALM in the past and it didn’t have the traceability I needed, especially tracing from my test executions and results. It also created duplicate work since I needed to go update my work there every time I completed a task. Ketryx updates itself as I’m working in Jira and GitHub. This tighter integration into our current tools helps us be more productive and release faster."

Aaron Berlin

SVP Development and Engineering

“Ketryx supports our system of systems architecture really easily out of the box. We were able to migrate our monolithic ecosystem into a single project and break it down into a desired state just within a couple of days. Ketryx delivered that because it was designed to scale. That was a huge plus.”

Emre Gültürk

VP of Regulatory Affairs and Quality Systems

“Ketryx has allowed us to channel our hardware and software engineers’ existing set of development, testing, and documentation practices directly into the generation of compliant documentation with minimal additional burden. This has allowed us to remain agile while delivering high-quality products.”

Alexander Chan

VP of Analytics and Machine Learning

Industries

IEC 61508 & ISO 9001 for functional safety

Medical Devices

FDA, MDR, ISO 13485 aligned development

Pharma and Biotech

GxP, 21 CFR Part 11 & GAMP 5 aligned validation

IEC 61508 compliant autonomous systems

ISO 26262 & ASPICE aligned lifecycles

DO-178C, DO-254, ARP4754A assurance

CMMC, MIL-STD-882E & 498 aligned mission systems

IEC 61513 & 60880 compliant digital I&C modernization

Pricing

Resources

Access Ketryx's extensive product documentation.

Learn about regulated medical device software development.

Support and FAQs

Customers submit tickets here for all product needs.

Hear from experts on regulated product development.

In-Person Events

Network with peers in life science and the Ketryx team

Take a deep dive into regulated software development.

Demo Video Library

See the Ketryx platform in action

About

Learn the origin story of Ketryx and how we got to where we are today.

Understand why regulated software teams choose Ketryx.

Learn about our team and opportunities to join us.

See recent press about Ketryx's work with life sciences teams.

See our compliance with international standards

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Risk Management in Jira and Ketryx

Ketryx incorporates 62304-compliant risk management functionalities into Jira, enabling continuous risk assessment and mitigation throughout the development process.

Recommended Videos

Risk Management in Jira and Ketryx

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