Product
Use Cases
Function
Capabilities
Integrations
What is Ketryx?
AI-native compliance for regulated medical applications
Read more
Solutions
Capabilities
Function
AI/ML in Medical Devices
Rapidly accelerate AI/ML software development and deployment, while staying compliant.
Hardware-Software Products
Unify compliance and accelerate development across mechanical, electrical, and software teams
SaMD and Connected Devices
Reduce the complexity, time, and cost of building SaMD (Software as a Medical Device) applications.
AI Governance for Life Sciences
Reduce the complexity, time, and cost of GxP validation for your application.
EU CRA
Meet EU Cyber Resilience Act obligations for SBOMs, vulnerability reporting, and 10-year technical files using your existing toolchain.
EU AI Act
Make EU AI Act compliance part of your development workflow.
Watch a short recorded demo
Jira for 62304
Transform Jira into a validated, compliant platform for medical device development.
AI Agents
Automate tasks with safety-critical AI agents that keep humans in the loop.
Enforcement
Enforce your QMS to ensure your team is following SOPs as you've defined them.
AI Change Impact Assessment
Apply AI to automate change impacts across your Design and Development File.
Compliance in your AI Tools
Real-time compliance context embedded directly into your IDE and LLM via MCP.
AI SDLC Transformation
Accelerate your AI maturity, guided by our experts.
AI Assistant
Generate artifacts, analyze traceability, and answer questions using real project context.
SBOM Management
Manage your software supply chain as part of a secure SDLC, from SBOM to release.
Requirements Management
Manage and trace requirements across connected systems like Jira.
Multifunction Devices
Independent device and non-device releases via system of systems.
Traceability
Automatic traceability across items, risks, code, and tests.
Risk Management
Control and document every risk automatically in a 14971-compliant way.
Traceability to Automated Tests
Automatically trace automated tests in Git to requirements in Jira.
Documentation
Automatically compile a submission-ready Design and Development File.
eQMS
Navigate compliance confidently without leaving your favorite tools.
System of Systems
Accelerate development and reuse components through a system of systems architecture.
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
Read more
Use Cases
AI/ML in Medical Devices
Rapidly accelerate AI/ML software development and deployment, while staying compliant.
Hardware-Software Products
Unify compliance and accelerate development across mechanical, electrical, and software teams
SaMD and Connected Devices
Reduce the complexity, time, and cost of building SaMD (Software as a Medical Device) applications.
AI Governance for Life Sciences
Reduce the complexity, time, and cost of GxP validation for your application.
EU CRA
Meet EU Cyber Resilience Act obligations for SBOMs, vulnerability reporting, and 10-year technical files using your existing toolchain.
EU AI Act
Make EU AI Act compliance part of your development workflow.
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.
Systems Engineering
Manage architecture and monitor change impact across the total product lifecycle
Watch a short recorded demo
Capabilities
Jira for 62304
Transform Jira into a validated, compliant platform for medical device development.
AI Agents
Automate tasks with safety-critical AI agents that keep humans in the loop.
Enforcement
Enforce your QMS to ensure your team is following SOPs as you've defined them.
AI Change Impact Assessment
Apply AI to automate change impacts across your Design and Development File.
Compliance in your AI Tools
Real-time compliance context embedded directly into your IDE and LLM via MCP.
AI SDLC Transformation
Accelerate your AI maturity, guided by our experts.
AI Assistant
Generate artifacts, analyze traceability, and answer questions using real project context.
SBOM Management
Manage your software supply chain as part of a secure SDLC, from SBOM to release.
Requirements Management
Manage and trace requirements across connected systems like Jira.
Multifunction Devices
Independent device and non-device releases via system of systems.
Traceability
Automatic traceability across items, risks, code, and tests.
Risk Management
Control and document every risk automatically in a 14971-compliant way.
Traceability to Automated Tests
Automatically trace automated tests in Git to requirements in Jira.
Documentation
Automatically compile a submission-ready Design and Development File.
eQMS
Navigate compliance confidently without leaving your favorite tools.
System of Systems
Accelerate development and reuse components through a system of systems architecture.
Integrations
Case Studies
Learn how the first company to bring GenAI to glucose biosensing maintains continuous compliance and traceability
Learn how Meta Reality Labs builds and ships regulated medical products without sacrificing engineering velocity
See how AI-powered Medtronic teams reduced documentation time by 90%
Learn how a top 3 pharma company took its software release cycle from 3 months to 1 week
Learn how a Fortune 50 company meets EU Cyber Resilience Act (CRA) requirements
See how Flo Health, with 430M users, transitioned to regulated development in just 90 days
Learn how an AI-powered radiology company accelerates product development while powering 20M+ annual scans
Discover how AI/ML-enabled cardiovascular MedTech company HeartFlow reduced complexity by 90% with a system of systems
Learn how Beacon Biosignals reduced their release cycle to two weeks for AI/ML products
Learn how Cytovale uses Ketryx to evaluate the impact of changes 70% faster
Discover how AI pathology company Aignostics stopped copying and pasting and accelerated their release cycle time
See how AI-enabled cardiovascular MedTech company Vektor Medical reduced documentation cycle time by 60%
“Ketryx enables asynchronous development of our product and the documentation required to stay compliant, move fast, and make high-quality AI products at scale.”
Ian Hanson
SVP of Engineering
“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 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 almost can't believe it, but as your website says, we did reduce our documentation time by over 90%.”
Senior Director, Quality
"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 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
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 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
"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
"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
“I almost can't believe it, but as your website says, we did reduce our documentation time by over 90%.”
Senior Director, Quality
“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.”
Alec Winograd
VP of Engineering
Industries
Physical AI
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
Robotics
IEC 61508 compliant autonomous systems
Automotive
ISO 26262 & ASPICE aligned lifecycles
Aerospace
DO-178C, DO-254, ARP4754A assurance
Defense
CMMC, MIL-STD-882E & 498 aligned mission systems
Nuclear Energy
IEC 61513 & 60880 compliant digital I&C modernization
Pricing
Resources
Documentation
Access Ketryx's extensive product documentation.
Blog
Learn about regulated medical device software development.
Support and FAQs
Customers submit tickets here for all product needs.
Webinars
Hear from experts on regulated product development.
In-Person Events
Network with peers in life science and the Ketryx team
White Papers
Take a deep dive into regulated software development.
Demo Video Library
See the Ketryx platform in action
About
Company
Learn the origin story of Ketryx and how we got to where we are today.
Why Ketryx
Understand why regulated software teams choose Ketryx.
Careers
Learn about our team and opportunities to join us.
Newsroom
See recent press about Ketryx's work with life sciences teams.
Certifications
See our compliance with international standards
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October 6, 2025
Unburdening Builders: Reinventing Regulated Development with AI
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