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Product

Capabilities

Function

Integrations



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.

Jira for 62304

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

AI Agents

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.

Traceability

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

Documentation

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

Enforcement

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.

eQMS

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.

AI Assistant

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

QA / RA

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

Dev / R&D

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

AI/ML Leaders

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.

Jira for 62304

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

AI Agents

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.

Traceability

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

Documentation

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

Enforcement

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.

eQMS

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.

AI Assistant

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

QA / RA

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

Dev / R&D

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

AI/ML Leaders

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

Integrations

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 Cytovale uses Ketryx to evaluate the impact of changes 70% faster

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

Learn how a F50 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%

See how Oui Therapeutics unified and accelerated their software development lifecycle

Ketryx was shown to have the potential to replace chasing documents with connected traceability. Critical engineering information that used to take hours to connect across multiple tools may now be done in minutes in one place with the help of Ketryx.

Cedar Farwell

Staff Product Development Engineer

“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

“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

“Overall we’ve been very happy relative to our previous workflow. Ketryx lets us get a lot more granular and more specific in terms of defining the configuration items. It maps much better onto our software development workflow and processes.”