Ketryx Launches First Validated AI Agents for Regulated Industries
Regulated product development teams now have a way to stay compliant while speeding up innovation. Ketryx introduces validated AI agents designed specifically for industries with strict safety and compliance requirements. These agents automate labor-intensive tasks like documentation and change management, allowing teams to focus on creating better products faster.
How Ketryx AI Agents Support Product Development
Regulated environments often require extensive documentation and adherence to numerous processes. This slows down product development, especially in fields like medical devices and life sciences. Ketryx’s AI agents tackle these challenges by maintaining human oversight in safety-critical decisions while handling repetitive tasks.
With tens of thousands of requirements and quality procedures often scattered across multiple tools, teams struggle to maintain traceability and process adherence. Ketryx’s solution integrates these fragmented systems, reducing the risk of conflicts and errors.
Key Features and Benefits
- Automate Documentation and Traceability: Reduce the time spent on documentation by up to 90%. The AI agents can define requirements, assess change impact, summarize key documents (like SRS or SDS), author specifications, suggest traceability links, and create test plans.
- Improve Quality and Compliance: The agents analyze your existing quality management system and compliance data to identify risks, gaps, and potential compliance issues. They provide clear instructions to ensure teams follow procedures and catch hidden problems.
- Accelerate Product Releases: Operating in a validated environment, the AI agents speed up change management by suggesting improvements, answering regulatory questions, and generating documentation. Human reviewers stay in control with simple approval workflows.
Validated AI Agents in Action
Here are some of the AI agents Ketryx currently offers or is preparing for validation:
- Complaint Agent: Automates complaint intake, instantly categorizes issues, and flags critical signals early to prevent quality problems.
- Redundancy Detection Agent: Identifies and removes duplicate or overlapping items in documentation and requirements.
- Test Coverage Analysis Agent: Assesses the completeness of test coverage relative to requirements and suggests improvements.
- Anomaly Review Agent: Reviews anomalies for accuracy and completeness, recommending enhancements.
- Change Request Review Agent: Evaluates product modifications, traces their impact, and highlights potential risks with actionable recommendations.
Customer Experience
Nicole Hollauf, Risk and Compliance Manager at Aignostics, highlights the impact: “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.”
Why This Matters for Product Development Teams
For product managers and developers working in regulated sectors, Ketryx’s AI agents offer a practical way to reduce manual work and increase confidence in compliance. By automating routine tasks without compromising safety oversight, teams can focus on innovation and faster delivery.
These agents work alongside existing tools, so teams don’t have to change workflows drastically. This integration helps maintain continuity while improving efficiency and quality throughout the product lifecycle.
Industry Perspective
According to Holger Mueller, Vice President and Principal Analyst at Constellation Research, “By automating the tedious aspects of documentation while maintaining human oversight and validation, Ketryx’s agents enable organizations to achieve both regulatory compliance and agile development—a combination that has been elusive until now. Companies that leverage these types of AI agents as an added layer of quality review will gain significant competitive advantages in time-to-market without sacrificing safety or compliance.”
Ketryx’s platform is already trusted by three of the world’s top five medical device manufacturers. It overlays existing systems, automating documentation, creating traceability, and accelerating release cycles without disrupting workflows.
For product teams aiming to reduce compliance burdens and speed up innovation in regulated industries, exploring AI-driven tools like Ketryx’s AI agents could provide practical benefits.
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