Real Progress
2 Hours to Real Progress – Free Work Session for Medical Device Software Teams
Not a sales call. Just real work, real results, zero strings attached. You bring the problem. I’ll bring clarity, tools, and forward motion.
This session is for leaders in medical device software—especially startups or early-stage teams—who want to move faster and stop guessing.
Common situations:
• You’re facing your first FDA 510(k) and don’t know where to start.
• You’re unsure if your documentation will hold up.
• You’ve heard about the new cybersecurity requirements but aren’t sure how to comply.
• Your team is drowning in documentation and V&V work.
• You’ve heard of eSTAR but don’t know what it means for your product.
Who This Is For
What Happens in the Session
This isn’t a discovery call. It’s a focused 2-hour work session.
Here’s how it goes:
We clarify your biggest blocker
You talk, I listen, we diagnose the real issue.
We create a targeted gap analysis
Where you are vs. where you need to be—fast.
We solve one real problem
Live work on diagrams, documentation, AI-powered jumpstarts, or architecture review.
You walk away with results
Tangible deliverables, real insight, and next steps—yours to keep.
Why I Offer This
Because showing is more powerful than telling.
You get real value: progress, clarity, and better outcomes.
I get to meet smart teams, sharpen my work, and sometimes earn future business.
No pitch. No pressure. Just impact.
What You’ll Leave With
Clarity on your regulatory journey
Real artifacts like diagrams or matrices
A focused set of immediate next steps
Peace of mind (and a lot less guessing)