Unburdening Builders: Reinventing Regulated Development with AI Use Cases Capabilities Function Integrations What is Ketryx? AI-native compliance for regulated medical applications Read more Solutions Capabilities Function Solutions AI/ML in Medical Devices Rapidly accelerate AI/ML software development and deployment, while staying compliant. SaMD and Connected Devices Reduce the complexity, time, and cost of building SaMD (Software as a Medical Device) applications. Jira for 62304 Transform Jira into a validated, compliant platform for medical device development. System of Systems Accelerate development and reuse components through a system of systems architecture. AI Governance for Life Sciences Reduce the complexity, time, and cost of GxP validation for your application. AI Change Impact Assessment Apply AI to identify, analyze, and act on change impacts across the DHF with less manual work and greater confidence. Traceability to Automated Tests Automatically trace automated tests in Git to requirements in Jira. Multifunction Devices Release device and non-device functions independently with a system of systems architecture. Watch a short recorded demo Capabilities AI Agents Automate arduous tasks across your toolchain with safety-critical AI agents that keep a human in the loop. SBOM Management See a single consolidated view of your open-source supply chain directly from your source code. Traceability Automatically create a real-time requirements traceability matrix by connecting items, risks, code, and tests from all your systems. Documentation Automatically compile all requirements, design inputs, outputs, and tests into a configurable and submission-ready design history file (DHF). Enforcement Enforce your QMS to ensure your team is following SOPs exactly as you've defined them. AI SDLC Transformation Accelerate your AI maturity, guided by our experts Requirements Management Manage and trace requirements across connected systems like Jira. Risk Management Control and document every risk automatically in a 14971-compliant way. eQMS Navigate compliance confidently with an eQMS that's interoperable with all your favorite tools. Watch a short recorded demo Function QA / RA Enforce your QMS procedures, prevent process deviation, and ensure your software is audit-ready 100% of the time throughout the SDLC. Dev / R&D Keep your developers working in their preferred DevTools while maintaining compliance and traceability. AI/ML Leaders Reduce your documentation burden by 90% and release your AI products faster. Systems Engineering Manage architecture and monitor change impact across the total product lifecycle Watch a short recorded demo What is Ketryx? AI-native compliance for regulated medical applications Read more Use Cases AI/ML in Medical Devices Rapidly accelerate AI/ML software development and deployment, while staying compliant. SaMD and Connected Devices Reduce the complexity, time, and cost of building SaMD (Software as a Medical Device) applications. Jira for 62304 Transform Jira into a validated, compliant platform for medical device development. System of Systems Accelerate development and reuse components through a system of systems architecture. AI Governance for Life Sciences Reduce the complexity, time, and cost of GxP validation for your application. AI Change Impact Assessment Apply AI to identify, analyze, and act on change impacts across the DHF with less manual work and greater confidence. Traceability to Automated Tests Automatically trace automated tests in Git to requirements in Jira. Multifunction Devices Release device and non-device functions independently with a system of systems architecture. Watch a short recorded demo Capabilities AI Agents Automate arduous tasks across your toolchain with safety-critical AI agents that keep a human in the loop. SBOM Management See a single consolidated view of your open-source supply chain directly from your source code. Traceability Automatically create a real-time requirements traceability matrix by connecting items, risks, code, and tests from all your systems. Documentation Automatically compile all requirements, design inputs, outputs, and tests into a configurable and submission-ready design history file (DHF). Enforcement Enforce your QMS to ensure your team is following SOPs exactly as you've defined them. AI SDLC Transformation Accelerate your AI maturity, guided by our experts Requirements Management Manage and trace requirements across connected systems like Jira. Risk Management Control and document every risk automatically in a 14971-compliant way. eQMS Navigate compliance confidently with an eQMS that's interoperable with all your favorite tools. Watch a short recorded demo Function QA / RA Enforce your QMS procedures, prevent process deviation, and ensure your software is audit-ready 100% of the time throughout the SDLC. Dev / R&D Keep your developers working in their preferred DevTools while maintaining compliance and traceability. AI/ML Leaders Reduce your documentation burden by 90% and release your AI products faster. Systems Engineering Manage architecture and monitor change impact across the total product lifecycle Watch a short recorded demo