You don't have an FDA problem. You have a project management problem.
Most medical device compliance failures — missed submissions, failed audits, stalled validation programs — trace back to one root cause: no one is truly owning the program. That's exactly what I do.
Fractional Project Management Executive
For organizations that need senior-level program leadership without a full-time hire.
For programs with uncertain completion dates — or at risk of falling behind.
Schedule Risk Analysis & Timeline Recovery
Using MS Project combined with Full Monte schedule risk analysis, I give you something most PMs can't: the actual probability your program will finish on time. Not a best guess. A data-driven risk percentage. Then I work with you to decide whether that risk is acceptable — or build a recovery plan to reduce it. You make decisions with real numbers, not hope.
You get a PMP-certified Program Manager embedded in your team — owning the schedule, driving cross-functional alignment, managing risk, and holding every stakeholder accountable to the timeline. I step in fast, ramp up faster, and operate like a trusted insider from day one.
Best for:
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Medical device companies with active FDA submissions, product development programs, or validation backlogs that need immediate senior leadership.
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Programs with aggressive FDA submission deadlines, complex multi-team dependencies, or executives who need defensible timeline data for board reporting.
Fractional Software Validation Program Leadership
For organizations facing FDA scrutiny, audit findings, or unvalidated software backlogs.
I assess, classify, and drive remediation of your software validation program — from legacy system inventories to full IQ/OQ/PQ validation packages. I've brought 40+ software systems into compliance across international sites and authored 200+ System Risk Classification documents. I don't just manage the process. I deliver audit-proof, submission-ready documentation that holds up under FDA scrutiny.
Best for: Companies undergoing warning letter remediation, preparing for pre-audit, or meeting 510(k) submission timelines.
Not sure which service fits your situation?
Book a free 30-minute strategy call. In 30 minutes, I'll tell you exactly where your program is at risk — and what it will take to fix it.