Multiple Function Device Validation
FDA-Grade AI Compliance for Multifunction Devices
Release device and non-device functions independently with a system of systems architecture.
With Ketryx, teams avoid being forced into all-or-nothing releases. Ketryx lets teams release non-device functions independently without re-validating the entire device, version device and non-device functions separately, reduce redundant validation cycles, and maintain patient safety with risk-based controls and traceability.
AI Regulatory Compliance
Release faster while staying compliant by separating device from non-device functions.
FDA guidance allows MedTech companies to separate device functions from non-device functions in multifunction devices. In theory, this means you only need to validate what’s regulated. In practice, most companies can’t take advantage because of their monolithic product architecture, the structure of their design controls, and their QMS.
That means a small change to a non-device function can trigger a full re-validation of the entire system. Development and release cycles slow down because teams can’t isolate device and non-device work, and Quality and R&D resources are drained by unnecessary compliance activities.
That means a small change to a non-device function can trigger a full re-validation of the entire system. Development and release cycles slow down because teams can’t isolate device and non-device work, and Quality and R&D resources are drained by unnecessary compliance activities.
Release Functions Separately with Ketryx
Ketryx makes FDA’s guidance actionable. Our system of systems architecture allows you to segment device and non-device functions, so you can validate only the regulated portions while continuing to develop, version, and release the rest of your product.
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How Heartflow Uses a System of Systems to Build AI SaMD Faster
Heartflow, a SaMD company serving 250,000 patients annually, needed to speed up development and release their AI-based software more frequently. By adopting a system of systems approach, Heartflow transformed their monolithic architecture into a modular, microservice-based system within 10 weeks. Ketryx facilitated the migration of thousands of artifacts, streamlining their architecture and enabling efficient code reuse, reducing complexity, and accelerating release cycles.
System of Systems
Release device and non-device functions separately with simple architecture segmentation
Ketryx lets you segment device and non-device functions into distinct systems. This separation enables teams to release updates to non-device functions without triggering re-validation of device functions.
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Documentation
Automatic documentation for multiple functions
By connecting requirements, risks, and tests across multiple projects, Ketryx provides a clear compliance boundary while ensuring that interactions between device and non-device functions remain fully documented.
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Risk Management
Reduce rework by catching issues early
Ketryx continuously monitors risk controls across all functions. Teams see unverified risks early in the SDLC, keeping device functions audit-ready while allowing non-device work to continue evolving independently.
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Traceability
Show traceability without the manual work
Ketryx generates real-time traceability between device functions, non-device functions, and associated risks. This makes it simple to demonstrate compliance for device functions while avoiding redundant validation of non-device functions.
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