What it Does
DeviceVynt™ supports post-clearance execution for medical device and SaMD teams. It helps teams identify misalignment between cleared intent, evolving execution, and AI usage early in day-to-day operations, before issues escalate into rework, inspections, or delays.
The outcome: faster execution with fewer interruptions. DeviceVynt operates after clearance and upstream of post-market surveillance.
Why Teams Use It
Support growth without slowing execution
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Reduce late-stage Regulatory Affairs intervention
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Keep product, commercial, and field teams aligned
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Preserve timelines without adding headcount
Who Its For
Regulatory Affairs & Quality
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Earlier visibility into post-clearance alignment and boundary signals
Product, Commercial Operations & Sales Enablement
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Cleaner execution, fewer corrections, faster enablement
Executive Leadership (GM, VP, CFO)
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Predictable timelines and protected commercial momentum
Digital, Procurement & IT
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Low-lift deployment within existing systems and controls.
Why Now
After clearance, many devices, rules and regulations, especially in software and AI-enabled products, keep changing.
When execution drifts faster than governance, risk accumulates quietly.
DeviceVynt™ surfaces that drift early, so teams can correct course while there’s still time.
What It Is Not
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Not a clearance or submission tool
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Not post-market surveillance
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Not clinical or patient-data related
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Not a replacement for RA or Quality
It supports post-clearance compliance continuity.
What it Does
DeviceVynt™ Tracks
Cleared intent & use boundaries
Regulatory classification signals (incl. SaMD)
AI governance boundaries
(use vs non-use, human-in-the-loop)
Claims and field messaging drift
Software and feature changes
Evolving regulatory expectations
(affecting execution)
Built to Fit Your Stack
DeviceVynt operates upstream of formal review and content systems, helping teams enter downstream workflows with cleaner, more defensible materials.
After clearance, devices, especially software and AI-enabled products keep changing.
When execution drifts faster than governance, risk accumulates quietly.
DeviceVynt™ surfaces that drift early, so teams can correct course while there’s still time
It can complement environments where teams use systems such as Veeva PromoMats®, helping content owners and cross-functional teams enter downstream review with greater alignment and fewer avoidable revisions.
Credibility and Assurance
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Human-in-the-loop by design – advisory support only
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No auto-approval – reviewers retain full authority
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Audit-ready workflows – time-stamped logs and version history
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Configurable controls – enterprise-aligned hosting and retention
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Workflow-compatible – operates upstream of existing systems
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Works Alongside Your Existing Review Systems
DeviceVynt™ is designed to operate upstream of enterprise content and review platforms, supporting cleaner execution before materials enter formal workflows.
DeviceVynt™ does not replace, modify, or automate decisions within formal review or approval systems.
Perform a 90 Day Pilot
Clearly defined metrics
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First-pass approval rate
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Revision count
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Cycle time
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Error-class reduction