Why Apsis CG?
FDA detours cost time and burn.
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One unclear requirement can add months—and millions—to your roadmap. We give startups concise, data-driven regulatory plans and lean ISO 13485 systems that move hardware, software, and AI/ML devices from prototype to clearance 30 % faster on average
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Who We Are
Engineers turned FDA strategists.
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MedTech veterans with 50 + years’ combined experience left Fortune-500 RA roles after watching breakthrough devices stall in review. We founded Apsis CG to pair deep FDA insight with true startup pace—so founders keep iterating while we turn regulations into clear approvals.
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Who We Serve
Built for First-Time FDA Founders.
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Seed to Series B teams building hardware, software, or AI/ML devices. We slot in as your fractional RA/QA arm—so you can focus on tech, fundraising, and patients while we handle the statutes, guidances, and reviewer questions
40
STARTUPS GUIDED
190+
DEVICES TOUCHED
3
CONSULTANTS
50+
YEARS OF MEDTECH RA/QA
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Fractional RA/QA Leadership
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Senior expertise, fraction of the cost
