Ketryx

• 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

Recently from Ketryx

Straight from the company's own channels.

Latest videos

103 subscribers · 41 videos

Visit channel

• How to Use AI to Generate Risk Assessments from Design Changes51 views · 3 weeks ago
• How to Use AI to Generate Tests and Close Coverage Gaps24 views · 4 weeks ago
• How to Use AI to Generate Design Inputs from User Feedback13 views · 4 weeks ago

From the blog

All posts

• Company blog·YesterdayAmerica’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 blog·Yesterday4 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 blog·2 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