[Skip to main content](https://www.ketryx.com/function/systems-engineering#)

[](https://www.ketryx.com/function/systems-engineering#)

This is some text inside of a div block.

Systems Engineering

# AI-Guided Systems Engineering for Safe, Compliant, Connected Development.

.png)

## 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

\\
\\
Case Study\\
**How HeartFlow Reduced Complexity by 90% in 10 Weeks with a System of Systems**](https://www.ketryx.com/case-studies/heartflow-case-study)

\\
\\
Webinar\\
**Jira for IEC 62304**](https://www.ketryx.com/learn/webinars/register/making-jira-fit-for-62304-developing-fda-compliant-software)

\\
\\
Blog\\
**Modernizing the Medical Device Factory to Work with Software**](https://www.ketryx.com/blog/modernizing-the-medical-device-factory-to-work-with-software)

\\
\\
Webinar\\
**Transitioning from Monolithic to Microservices: How to Adopt a Systems of Systems Approach for Your SDLC**](https://www.ketryx.com/learn/webinars/register/transitioning-from-monolithic-to-microservices-how-to-adopt-a-systems-of-systems-approach-for-your-sdlc)

\\
\\
Case Study\\
**How a Medical Diagnostics Leader Reduced Change Impact Assessment from Days to Minutes with Ketryx AI**](https://www.ketryx.com/case-studies/change-impact-ketryx-ai)

\\
\\
Case Study\\
**How a Top 5 MedTech Company Assessed Vulnerabilities 80% Faster**](https://www.ketryx.com/case-studies/assess-vulnerabilities-faster)

### **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.

[Explore Traceability](https://www.ketryx.com/capabilities/traceability)

[Quickly identify coverage gaps and see how all risks, specifications, tests, and requirements are connected throughout development.](https://www.ketryx.com/function/systems-engineering#)

[Prevent dangling items, such as requirements, risks, and tests, from being directly in your existing tools.](https://www.ketryx.com/function/systems-engineering#)

[Automatically generate real-time traceability matrices across any system and other FDA-ready documentation with a single click.](https://www.ketryx.com/function/systems-engineering#)

### **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.

[Explore AI Agents](https://www.ketryx.com/capabilities/ai-agents)

[Surface conflicting requirements 95% faster, preventing costly late-stage compliance risk.](https://www.ketryx.com/function/systems-engineering#)

[Expose test coverage gaps up to 90% faster, and make sure that every requirement and risk is fully tested.](https://www.ketryx.com/function/systems-engineering#)

[Let agents review documentation and flag inconsistencies, dramatically reducing manual review time and preventing gaps from slipping through](https://www.ketryx.com/function/systems-engineering#)

### **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.

[Explore Risk Management](https://www.ketryx.com/capabilities/risk-management)

[Surface high-risk items fast to focus work on where it has the biggest impact and address the most severe risks first.](https://www.ketryx.com/function/systems-engineering#)

[Automatically highlight unverified risk controls so releases only move forward when every mitigation is validated.](https://www.ketryx.com/function/systems-engineering#)

[Quickly review risk documents to confirm that every risk is managed and documented according to internal SOPs and industry standards.](https://www.ketryx.com/function/systems-engineering#)

### **Change Impact Assessment**

Instantly understand the impact of any change across your entire system, no matter where artifacts live.

[See Change Impact Assessment](https://www.ketryx.com/impact-assessment-workflow)

[Reduce Impact Assessment planning time by 70% by using Change Impact Assessment Agents.](https://www.ketryx.com/function/systems-engineering#)

[Built in QMS-specific compliance agent surfaces gaps proactively and before any change request is approved.](https://www.ketryx.com/function/systems-engineering#)

[Automatically surface downstream and upstream impacts across end-to-end traceability whenever requirements, risks, or code change.](https://www.ketryx.com/function/systems-engineering#)

[Eliminate the manual, error-prone work of evaluating change impacts throughout development; replace spreadsheets and guesswork with automated, audit-ready impact analysis.](https://www.ketryx.com/function/systems-engineering#)

### **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.

[Explore Integrations](https://www.ketryx.com/capabilities/integrations)

[Sync development and test tools to align with requirements, ensuring teams are working with and testing the right things.](https://www.ketryx.com/function/systems-engineering#)

[Real-time trace matrix keeps traceability up to date throughout development.](https://www.ketryx.com/function/systems-engineering#)

[Give developers the freedom to work in their preferred tools while providing systems engineers visibility across tools.](https://www.ketryx.com/function/systems-engineering#)

## 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

Align Quality with Development

## Ketryx bridges the gap between R&D and Quality for higher productivity and enhanced collaboration.

[Watch webinar](https://www.ketryx.com/learn/webinars/register/empowering-sdlc-process-tools-bridge-rd-quality)

.png)