Ketryx for IVD
Automatically update your IVD technical file.
Keep design inputs, risk controls, and verification and validation evidence automatically linked as work happens, so your IVD technical file stays current.
Problem
The technical file falls behind the moment development begins.
An IVD's technical file spans the instrument, software, algorithm, reagents, and clinical performance evidence. Each lives in a different system, so reconciling them into one coherent submission is manual, often late, and repeated in full for every filing and algorithm update.
Ketryx Solution
One connected system for the whole technical file.
Ketryx integrates with the tools your teams already use, like Jira and GitHub, and transforms them into a self-documenting, self-enforcing, self-tracing validation record.
Live Traceability Across The Technical File
The technical file becomes a live view of the design, updated as work happens.
Requirements, risks, design outputs, and verification and validation evidence live as connected, controlled records, and a real-time traceability matrix shows how they depend on and relate to each other.
See a live traceability matrix
Design inputs, risk controls, and verification and validation evidence, linked in one record.
Traceability visible at any moment, not assembled before a submission.
Documentation
Human-in-the-loop approval gates every release.
Configurable approval workflows keep a person in the loop at every lifecycle transition, so nothing moves forward without sign-off. Verification and validation evidence, and the design-control records behind it, are captured, controlled, and traced in real time, instead of assembled by hand before a filing.
Learn more about documentation
Design input approved and e-signed.
Verification and validation records released under configurable approval, not assembled by hand.
Change Control & Targeted Reverification
A single change gets targeted, risk-based re-verification.
Changes are verified and validated incrementally with a risk-based approach, so a software update ships with right-sized, targeted re-verification against the affected requirements, instead of re-verifying everything from scratch.
Learn more about automating change impact
Nonconformances, change requests, and CAPAs stay linked to the systems, risks, and tests they affect.
An algorithm retrain or software update surfaces its impact on analytical or clinical performance; whether that requires performance re-establishment or a new submission is a decision your team makes, not the system.
AI/ML Lifecycle & Drift
Risk controls that stay traceable as the model retrains.
Models are managed under a living quality system, where design inputs, ISO 14971 risk controls, and verification and validation evidence stay traceable and audit-ready as the model drifts and retrains.
Learn more about AI/ML
Model qualification and risk controls, linked from the start.
Drift and performance monitoring stay continuous; retraining is gated by human approval.
Quality & Data Integrity
Every record, approved and signed, reviewed before it counts.
Configurable approval workflows and electronic signatures gate every record, with a 21 CFR Part 11 audit trail capturing who changed what, and when.
Learn more about enforcement
Requirement, change request, complaint, and anomaly records reviewed automatically for quality issues before they reach a person.
Requirement conflicts, unlinked tests, and redundant records flagged for a person to resolve.
Companion diagnostics
A companion diagnostic couples software, hardware, and reagents to produce a result that determines therapy eligibility. Ketryx keeps design inputs, risk controls, and verification and validation evidence traceable across all three, so a change in one surfaces its impact on the other two instead of being assessed in isolation.
Software
The algorithm's design inputs, risk controls, and verification and validation evidence stay linked to the instrument and the assay.
Hardware
The instrument's specifications and risk controls stay linked to the algorithm and the assay.
Reagents
The assay's specifications and performance evidence stay linked to the algorithm and the instrument.
Case study
From quarterly to weekly: how a Fortune 500 diagnostics company transformed its release cycle
One of the world's largest in vitro diagnostics (IVD) companies develops software-driven diagnostic systems used in clinics and laboratories worldwide. After implementing Ketryx, the company reduced its end-to-end release cycle from three months to one week, shortened documentation time by 70%, and eliminated more than half of its existing tooling costs. Engineering and quality teams that once spent release cycles catching up on compliance now reinvest that capacity toward advancing the product.
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