Product

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.

AI for Life Sciences (GxP)

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

Component Reuse

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

Traceability to Automated Tests

Automatically trace automated tests in Git to requirements in Jira.

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.

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 history file (DHF).

Enforcement

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

SBOM

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

Integrations

Integrate Ketryx with your preferred DevTools to automatically establish traceability, create documentation, and enforce your QMS.

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.

Watch a short recorded demo

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.

Watch a short recorded demo

What is Ketryx?

Connected Lifecycle Management platform 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.

AI for Life Sciences (GxP)

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

Component Reuse

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

Traceability to Automated Tests

Automatically trace automated tests in Git to requirements in Jira.

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.

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 history file (DHF).

Enforcement

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

SBOM

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

Integrations

Integrate Ketryx with your preferred DevTools to automatically establish traceability, create documentation, and enforce your QMS.

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.

Watch a short recorded demo

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.

Watch a short recorded demo

Case Studies

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

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

See how AI-powered nutrition platform Nutrino reduced SBOM documentation time by 90%

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

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%

See how Oui Therapeutics unified and accelerated their software development lifecycle

“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.”