The most intuitive platform for building FDA-compliant software
21 CFR Part 11/Part 820, ISO 13485, IEC 62304, and ISO 14971
Empower Agile software and testing teams
Embed the validated application life cycle management process into Jira allowing developers to use the tools they love.
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Trace the project at every stage
Track release progress with complete traceability of requirements, tests, software specifications and implementations.
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Monitor and secure your software supply chain
Manage approval of direct dependencies with user-specified approval groups. Monitor dependency vulnerabilities with automatically updated CVSS v3.0 severity ratings.
the Ketryx Jira Connector
Create regulated applications 2-3X faster.
Get started building software in minutes, not months.