A 30-minute discovery call with Andre Butler gives you a clear-eyed assessment of your device's regulatory situation — no generalist advice, no templates. Andre has guided medical device companies through more than 100 FDA submissions across Class I, II, and III device categories, including high-stakes 510(k)s, De Novo classifications, and AI/ML SaMD pathways.
Whether you are preparing a first submission, responding to FDA 483 observations, or trying to determine the right regulatory pathway for a novel device, the discovery call is the fastest way to get your specific questions answered by an FDA regulatory consultant with real practitioner experience.
The call is free and there is no obligation. Most clients leave with a written summary of their regulatory situation and a clear set of recommended next steps.
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Common Questions
Yes — no hidden fees, no obligation. We believe the fastest way to earn your trust is to provide genuine value upfront: an honest assessment of your situation, not a sales presentation.
For standard engagements, typically within 1–2 weeks of signed agreement. For FDA 483 emergency response, we can mobilize within 24–48 hours of initial contact.
Absolutely. Some of our most valuable engagements are with startups building their first device. Avoiding early regulatory missteps saves significant time and capital down the road.
We regularly take over mid-submission projects, conduct submission reviews, or provide second opinions. Bring us in at any stage — we'll assess where you stand and what it takes to reach clearance.