Ketryx
Software & Technology
Ketryx is an AI-native compliance and Application Lifecycle Management (ALM) platform for regulated software development, primarily in medical devices and life sciences. Its platform automates documentation, traceability, risk management, and QMS enforcement so teams can develop FDA- and EU MDR-compliant software in tools like Jira and GitHub.
- AI-native compliance / ALM platform for regulated software development
- Automated documentation and submission-ready Design and Development File generation
- Traceability across requirements, risks, code, and tests
- Risk management (ISO 14971) and SBOM management
- eQMS with QMS enforcement
- Integrations including Jira ("Jira for 62304"), GitHub, and IDE/LLM compliance via MCP
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Company blogYesterdayAmerica’s Great AI Freakout Has BegunAI safety is finally a kitchen-table conversation. As public awareness surges, lawmakers and industry are getting serious about rules of the road.Read post
Company blogYesterday4 questions about the FDA’s approach to generative AIThe FDA has cleared 1,500+ AI devices but no generative AI tools yet, and its new discussion paper proposes competency-based assessment and postmarket monitoring as the path to get there.Read post
Company blog2 weeks agoThe VentureFizz Podcast with Erez KaminskiAs I’ve covered in multiple episodes of The VentureFizz Podcast, all industries are ripe for disruption with AI, especially life sciences. However, life sciences is difficult because it is heavily…Read post
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Unspecified / Hybrid
Vienna, Vienna, Austria
Manager
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- Product Management
Posted 4 months ago
Source: Greenhouse
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