SaMD Compliance Software
Software as a Medical Device (SaMD) and Connected Devices
Reduce the complexity, time, and cost of building Software as a Medical Device (SaMD) applications with the only developer-first connected lifecycle management platform.
FDA Software as a Medical Device
Build safe and reliable FDA-compliant SaMD faster
Software is at the core of most medical devices. But today’s software landscape is increasingly complex. Methods of the past don't scale for the software of today. Quality and development teams alike are looking for a better way to release faster, safer software, at scale.
Documentation
Accelerate SaMD releases
Software developers new to safety-critical environments often struggle to integrate modern software development methodology with the documentation required to ensure patient safety and regulatory compliance.
We spoke to dozens of quality experts and nobody ever made anything clear to us. The team at Ketryx did. For the first time, they helped us really understand how to develop compliant software. With Ketryx, our team is truly happy and productive.
Alec Winograd, VP of Engineering at Oui Therapeutics
Higher productivity. Greater control.
Designed with built-in compliance, Ketryx integrates with DevTools like Jira and GitHub and transforms them to create a self-documenting, self-enforcing, and self-tracing software development lifecycle.
Traceability
Maintain digital knowledge continuity with self-tracing compliance software
Establish traceability as you build your medical device
Explore traceability
Understand and categorize each item in your system with simple, readable labels.
Trace team actions, keep every team member up to date with the latest data, and follow actionable prompts.
Use a self-contained system and lower the barrier for onboarding and teaching new team members.
Cybersecurity
Simplify management of your software supply chain
Automatically generate an FDA-compliant SBOM
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Empower developers to use open-source software by creating a real-time single source of truth for your FDA-compliant Software Bill of Materials (SBOM) and SOUP.
Shift-left your cybersecurity with real-time vulnerability scanning and management across your software supply chain.
Guided cyber risk analysis and reliability analysis incorporated directly into the tools and workflows your teams already use.
Enforcement
Prevent process deviation in your DevTools
Enforce your QMS throughout your developers' tools.
Explore enforcement
Ensure that SOPs are applied in all of your team’s DevTools.
Structured guidance appears as a checklist so everyone knows what they need to do next.
Maintain FDA-compliant data integrity.
Risk Management
Easy, actionable guidance to accelerate FDA compliance
Stay compliant with ISO 14971 with integrated risk management workflows
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Guided change control ensures that any change released is audit-ready and FDA-compliant.
Automatically generate all design control documents, testing reports, and other required artifacts.
Ketryx provides a framework that enforces FDA-required information within tools the team already uses, like Jira
Postmarket Surveillance
Accelerate patch releases and new versions of your SaMD
Release faster while maintaining control across versions.
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Release patches and new versions quickly.
Granular trace matrix filters let you easily compare changes between versions.
Manage complaints and changes across multiple versions.
Accelerate development across your AI lifecycle with Ketryx.
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