Clarity.
Capability.
Compliance.
Delivered.
Turning vision into impact
“We help HealthCare leaders and executives turn strategy into regulatory success—fewer recalls, faster clearances, and stronger R&D and PMO performance.”
––Michael Dabis, Founder & Principal, ClariVantage LLC
For Startups
Launching a HealthCare product is daunting; limited resources, unclear regulatory pathways, and fragmented R&D strategies often stall progress. Are you struggling to gain FDA clearance, align your innovation with regulatory expectations, or simply get to market faster and safer?
For Established Companies
Are your projects chronically delayed, your teams siloed, or your innovation pipeline underperforming despite scale? Is your organization burdened by legacy systems, excessive complaint rates, or regulatory fire-fighting that consumes your best talent? No matter your size you don’t have to navigate these challenges alone. We offer proven solutions that align strategy, operations, and compliance.
Why ClariVantage?
Strategy Meets Execution
With 20+ years of end-to-end experience, we can own and execute initiatives independently.
We collaborate effectively across various departments to optimize speed, ensure compliance, enhance marketing strategies, provide exceptional services, maintain high quality standards, and foster innovation at every stage of your product lifecycle.
Strategy to Execution
At ClariVantage, strategy isn’t where the work ends; it’s where measurable impact begins. We bridge the gap between high-level direction and day-to-day execution by embedding directly with your teams, translating complex strategies into actionable roadmaps, and ensuring alignment from boardroom to bench. With 20+ years across R&D, regulatory, and PMO leadership, we have helped HealthCare companies move from vision to velocity; delivering faster regulatory clearances, leaner development processes, and reduced quality issues. Whether you’re building a product pipeline, re-aligning investment portfolios, or standing up a global PMO, we turn strategic intent into operational results.
Global Clearance Expertise
Navigating regulations requires more than checklists; it demands strategic foresight, cross-functional coordination, and deep domain expertise. At ClariVantage, we help HealthCare innovators accelerate regulatory approval without compromising quality or compliance. We have led multiple Class II medical devices through successful 510(k) submissions, including under consent decree conditions. By embedding compliant processes, and aligning teams early in development, we have enabled projects to reach market faster. Whether you’re a startup preparing your first submission or an enterprise remediating legacy gaps, we bring hands-on experience to reduce risk, accelerating timelines, and deliver regulatory success.
R&D & PMO Efficiency
Effective innovation demands more than technical excellence; it requires structured execution and strategic governance. At ClariVantage, we help HealthCare companies modernize their R&D operations and establish high-impact PMOs that accelerate development and reduce waste. We have led transformations that cut late-stage project overruns by 63%, built global PMOs overseeing 200+ initiatives, and realigned $80M in R&D budgets to match business priorities. Whether you’re launching a new program or scaling enterprise-wide governance, we bring the frameworks, tools, and leadership to drive cross-functional alignment and measurable outcomes. From agile/LEAN pilot teams to enterprise PMO overhauls, we turn fragmented execution into focused delivery.