Systems Engineering
AI-Guided Systems Engineering for Safe, Compliant, Connected Development.
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Unify your ALM, PLM, risk management, and testing tools into a single compliant ecosystem and use AI agents to flag safety-critical issues faster.
Managing traceability of complex systems
Systems Engineers ensure every requirement, risk, design input, and test is traceable and compliant.
Complete traceability is essential to proving your product is safe, effective, and compliant. However, fragmented tools and rapidly emerging technologies add new layers of complexity that Systems Engineers must navigate and control.
Fragmented Tools
Maintaining traceability across requirements, design, risk, and verification is overwhelming, especially with traditional tools like spreadsheets. Fragmented ALM, PLM, risk, and testing tools leave teams stitching together custom scripts and manual updates to manage traceability.
Managing Change Control
Every change to requirements, design, or verification creates a ripple of updates, versions, and QMS steps that Systems Engineers must manually track. Progress blurs into stress, creating risk of missed updates, rework, and audit findings.
Balancing Innovation and Compliance
As emerging technologies like AI and automation are introduced into products, system complexity grows, creating new challenges in traceability, risk, and testing that Systems Engineers must manage.
Resources for Medical Device Software Engineering Leaders
Establish End-to-End Traceability
Automatically trace requirements, risks, designs, tests, and code, even when they reside in different tools, so you always have complete, audit-ready traceability.
Agents Identify Safety Critical Gaps
Proactively flag safety-critical gaps or issues. Ketryx Agents continuously scan your ecosystem to identify potential problems while keeping a human in the loop to take action.
Enable Comprehensive Risk Control
Reduce hours of manual risk control verification with automated oversight that enables you to confirm every mitigation is implemented, validated, and compliant with internal SOPs and industry standards.
Change Impact Assessment
Instantly understand the impact of any change across your entire system, no matter where artifacts live.
Connected Tools
Connect your existing ALM, PLM, requirements management, risk, and testing tools to Ketryx’s validated ecosystem to maintain real-time, cross-tool traceability.
Ketryx gives me confidence that the entire team is working from a single source of truth. We can move quickly without second-guessing whether we’re adhering to our standards or processes, which allows me to focus on solving real technical problems instead of managing manual documentation.
Director of Systems Engineering
Ketryx bridges the gap between R&D and Quality for higher productivity and enhanced collaboration.
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