Ketryx Wants Its Validated AI Agents To Accelerate Compliance Workflows

This article originally appeared in citeline.com on May 15, 2025.

In the not-so-distant future, the tedious process of compiling documentation for FDA audits, managing sprawling software requirement logs, or keeping pace with regulatory shifts might no longer rest on overworked compliance officers – but on tireless, validated AI agents. And if Ketryx has its way, the future is already here.

The Boston-based start-up announced the commercial launch of the first validated AI agents purpose-built for regulated industries – a step founder and CEO Erez Kaminski hopes will catalyze a fundamental shift in how safety-critical products are developed and brought to market. The agents are designed to off-load much of the burdensome documentation and change management work that has historically slowed innovation across medtech and other highly regulated industries, while keeping human oversight firmly in place.

“Regulated companies are stuck in a paradox,” Kaminski told Medtech Insight in an exclusive interview. “The systems that are meant to ensure safety also slow teams down to the point where their best engineers are spending more time formatting documents than solving patient-critical problems. That’s the problem we’re solving.”

Validated AI For A New Regulatory Era

Kaminski says the company’s AI agents aren’t generic chatbots or experimental copilots, but instead validated digital workers engineered to operate within regulatory boundaries and audit frameworks. This includes traceable activity logs, human-in-the-loop oversight, and controlled performance verification, much like how medical devices must be validated for clinical use.

“When we say an AI agent is validated, we mean we’ve defined a specific task – such as classifying complaints or tracing risks – and we’ve demonstrated, with audit-ready evidence, that the agent can perform that task reliably and safely,” said Kaminski. “It’s not about perfection; it’s about trustworthiness within known limits.”

Ketryx’s validation methodology includes real-world stress testing, error margin tracking, and system-level traceability to help clients prove to regulators that AI-assisted workflows still meet Good Automated Manufacturing Practice (GAMP) and IEC 62304 expectations.

Paul Jones, Ketryx’s VP of Regulatory Affairs and a co-author of IEC 62304, has been central to the company’s regulatory strategy. “From the beginning, we thought about validation through the lens of the [US Food and Drug Administration],” Kaminski said. “These agents don’t replace human judgment – they support it. Regulators care about audit trails and process integrity, and our system enhances both.”