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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
Cybersecurity
Enforcement
Risk Management
Postmarket Surveillance
Traceability

Maintain digital knowledge continuity with self-tracing compliance software

Establish traceability as you build your medical device
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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
Explore SBOM
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.
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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.
Schedule a demo
Release patches and new versions quickly.
Granular trace matrix filters let you easily compare changes between versions.
Manage complaints and changes across multiple versions.