Introducing Agentic AI for Safety-Critical Software

AI Agents for Regulated Software Teams

Ketryx AI Agents help you enforce compliance, maintain documentation integrity, and surface traceability gaps—while keeping full control in your hands. Agents continuously scan across your connected systems to find the things humans miss, suggest improvements, and act with your approval.

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The Exponential Complexity of Compliance

Why AI Is Essential in Highly Regulated Environments

When teams work across fragmented tools, traceability breaks down fast—making it hard to connect requirements to tests, align evidence with procedures, or catch documentation gaps before an audit. The result? A higher risk of rework, audit delays, and missed compliance steps, all while draining resources through manual documentation.

30-40% Increase in project costs when validation is required (Gartner 2022)

12-18% Share of industry revenue consumed by quality assurance overhead (McKinsey & Company)

Specialized AI Agents for High-Impact Compliance Work

Ketryx Agents are purpose-built, AI-powered teammates for regulated product teams. Working with knowledge of your QMS, each AI agent connects to your tools to detect issues, draft documentation, and recommend actions, always surfacing changes for human review.

Change Impact Assessment

Review change impacts 70% faster and understand the scope early. Agent scans requirements, test cases, artifacts, and documentation, then identifies and recommends updates.

Redundancy Detection Agent

Identify redundancies 85% faster. Scans requirements, detects duplicate or overlapping items, and recommends fixes so that teams aren't uncovering duplication in final documentation or at the end of the release cycle.

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Requirement Conflict Agent

Review conflicting requirements 95% faster. Automatically detects and flags conflicting requirements so you can catch issues early, avoiding costly rework and reducing compliance risk.

Change Request Review Agent

Reduce rework by 80%. Verifies that every change request has all the appropriate fields filled out, flags any gaps, and suggests updates for completeness and consistency.

Test Coverage Agent

Analyze test coverage 90% faster. Scans tests and requirements to evaluate test coverage and surface gaps, so you can confirm that everything that needs a test has one.

Complaint Agent

Triage complaints 80% faster. Streamlines complaint intake, documents and categorizes complaints instantly, and flags critical signals so you can uncover quality issues early.

Anomaly Review Agent

Review anomalies 90% faster. Verifies the completeness of anomaly records in your system (like checking for root causes), flags missing evidence, and suggests updates so that critical anomalies don't get overlooked.

Anomaly Scoping Agent

The anomaly scoping agent drafts a complete impact assessment and regression test plan in minutes, analyzing your design and development history file, QMS, and regulatory standards through deterministic traceability to pinpoint exactly which test cases need re-execution and what an anomaly affects across the product. SMEs then review and approve the agent's output, so teams stay in control while bypassing the manual scoping work that normally bottleneck anomaly resolution.

Custom Agent

Embed Custom AI Agents directly into your workflows to analyze your DHF, evaluate change impacts, suggest traceability updates, and author reports.

Human-in-the-loop control

No change ships until you approve the agent’s recommended changes.

Proactive issue detection

Agents flag conflicts and gaps before audits or releases.

Accelerate critical tasks

Automate specs, trace links, and risk docs in minutes.

4 of the Top 5 Medical Device Leaders Use Ketryx

“We use Ketryx to analyze risks, find incomplete or missing risks, and trace requirements to the associated risks. Previously, this process was manual, so Ketryx gives us a repeatable quality process, saves us time, and helps us release faster while also ensuring that we have controls for all risks.”
Nicole Hollauf
Risk and Compliance Manager

A Smarter AI Workflow—With a Human at Every Level

Ketryx AI Agents use Large Language Models (LLMs) to interpret natural language queries, retrieve information, and generate content about your software project. All interactions occur via a zero data retention endpoint, meaning data is processed in-memory only and never stored or used to train models. Agents can’t take any action without human approval.