Every month your FDA submission slips, your competitor owns your market.

 

I'm Curtis Griffy — a Fractional Project Management Executive who steps in, owns your submission timeline, and gets your medical device program across the finish line. My current client has renewed me 16 consecutive times. They won't let me go.

 

PMP-Certified · 15+ Years in Medical Devices · FDA 21 CFR 820 · IEC 62304 · $4.4M Programs Delivered On Time · Zero Warning Letters on My Watch

 

Book Your Free 30-Minute Strategy Call

Find out in 30 minutes if your FDA submission timeline is at risk — and what to do about it.

"Calm, steady, and always willing to go the extra mile to remove roadblocks." — Sharon Odland, Abbott

"You're on your 6th extension because you make your clients' lives easier — and you have their success at the heart of everything you do." — Cat Breet, Client Stakeholder

Does This Sound Familiar?

  • Your FDA submission deadline is real — but nobody is truly owning the timeline.

  • Your software validation backlog keeps growing and the audit is getting closer.

  • Your cross-functional teams are misaligned and the program keeps slipping.

These aren't technical failures. They're project management failures. And they're entirely preventable.

 

I step in fast, ramp up faster, and operate like a trusted insider from day one. I build the structure that didn't exist, align your teams, own your submission timeline, and deliver audit-proof results that hold up under FDA scrutiny.

You get executive-level program leadership — without the executive-level price tag.

Is your FDA submission timeline at risk?

Book a free 30-minute strategy call. I'll tell you exactly where your program is vulnerable — and what to do about it.