Automated and traceable
Manage your SDLC across systems
Developing regulated software is complex. Ketryx connects across your systems to impose control on preferred DevTools throughout the lifecycle, from planning to post-market.
Software Manufacturing Process
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Planning & Research
Define project scope, objectives, and gather user requirements, while conducting preliminary market and technical research.
Risk Analysis
Identify potential risks associated with the software and assess their impact on patient safety and product performance.
Design
Create detailed software architecture and design specifications, ensuring compliance with regulatory standards.
Develop
Write and compile the code based on design specifications, integrating necessary functionalities.
Deploy
Install the software on the intended hardware or platform for initial testing and use.
Test
Conduct thorough testing, including unit, integration, and system tests, to verify software functionality and reliability.
Verification & Validation
Confirm that the software meets all specified requirements and intended use through rigorous testing and evaluation.
Final Risk Analysis
Reassess risks post-development to ensure all potential hazards have been mitigated or controlled.
Release
Prepare and approve the software for market release, ensuring all regulatory and quality requirements are met.
Distribution
Distribute the software to end-users or customers, ensuring proper documentation and support are provided.
Postmarket Surveillance
Monitor the software's performance and safety in the market, gathering user feedback and addressing any issues or updates needed.
What is Ketryx?
Regulated software lifecycle management
Change management
Automate change control processes and trace changes across the SDLC.
See how it works
Documentation
Automatically compile all requirements, design inputs, outputs, and tests into a configurable and submission-ready design history file (DHF).
Explore Documentation
Requirements management
Manage requirements in Jira or your tool of choice.
Explore requirements management in Jira
Version control
Use the release dashboard to quickly compare changes between versions.
See how it works
Automated testing
Connect and trace automated tests to requirements, risk controls, and specifications.
How we trace to automated tests
SBOM
See a single consolidated view of your open-source supply chain directly from your source code.
Explore SBOM
Vulnerability management
Automated vulnerability detection helps you quickly evaluate risk.
Explore Vulnerability Management
Integrations
Connect your preferred DevTools into a single, traceable SDLC.
See available integrations
Risk management
Proactive monitoring identifies potential risk and security vulnerabilities.
Explore Risk Management
Streamline your workflow
Ketryx integrates with these tools and more
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