AlphaSPIKE (fdarisk.com) Information

Riskbased.ai, a KeyPedia company, is the intelligence layer for FDA-regulated medical devices. We transform fragmented MDR and post-market data into actionable risk signals, connecting surveillance, quality, and regulatory workflows so teams can detect emerging issues earlier, quantify risk, and act before problems escalate. Tools including AlphaSPIKE, MAUDE 3.5, and FDA God’s Eye help Quality, Regulatory, Clinical, and executive teams move from reactive compliance to proactive intelligence—compressing the time from signal to decision to action and reducing patient harm.