Ketryx, an AI-powered life sciences company, has launched what it says are the first AI agents to automate compliance processes in regulated industries.
Described as “validated” agents, the new system is designed to assist businesses in closely controlled environments such as life sciences and medical devices, promising to resolve regulatory conflicts in the process of product design and development.
Erez Kaminski, Ketryx’s CEO, told AI Business the agents differ from other AI tools on the market because they “operate within the complete context” of a businesses’ system.
“Ketryx is configured according to a company’s quality management system and processes…so each agent cannot take action outside of an organization-specific, deterministic ruleset,” Kaminski said.“Ketryx also connects to the systems that teams are using to do their work, like Jira or GitHub, giving agents a 360-degree view of requirements, code, risks and tests; this lets them spot traceability gaps or conflicting items that point solutions can’t see.”
Kaminski said the agents work to reduce costs and human fatigue by automating admin tasks such as data analysis and document creation. He said the validated agents also respond to industry pain points, such as cybersecurity threats and the need for time to act on complaints.
“Today, a single software patch can take nine to 12 months to deploy because teams have to manually rebuild trace matrices and their technical documentation. Our agents collapse that cycle to weeks or even days,” he said. “The ultimate goal is to help the industry achieve zero-lag safety—where safety-critical issues are identified, investigated, and addressed as they happen, not months or years later.”
AI Agents Now Available
Ketryx is rolling out a suite of pre-built agents that are pending validation, including a Complaint Agent that flags quality issues from customer feedback, a Redundancy Detection Agent to identify duplicate or overlapping data and an Anomaly Review Agent for evaluating data irregularities, among others.
Already available is the Ketryx Requirement Conflict Detection AI Agent, pitched as the first validated AI agent specifically designed to support FDA-class, safety-critical work.
Agent capabilities include drafting specifications, generating traceability links and summarizing key development documents, and according to Ketryx, can reduce documentation by 90%.
Importantly, Kaminski notes, these agents all keep human input at their heart.
“These agents maintain human-in-the-loop oversight for safety-critical decision making so that regulated teams can leverage the power of AI to generate documentation and accelerate product delivery, but the critical decision making remains under human purview,” Kaminski said.
The Future of AI Agents
Looking ahead, Kaminski said AI agents are likely to become standard practice across businesses, due partially to the FDA’s push for Predetermined Change Control Plans and the EU MDR’s emphasis on real-time post-market surveillance.
To stay ahead of this trend, Kaminski said Ketryx is planning to expand its AI agent offerings beyond conflict detection and complaint processing into areas like predictive risk analysis, auto-generated test protocols and continuous compliance.
“Imagine a future where a new vulnerability or requirement change triggers an agent to not only flag it, but draft mitigations, propose fixes and update documentation automatically — all fully traceable and audit-ready with human review,” he said. “That’s the future we’re building. And we’re just getting started.”