Case Study: Potrero Medical achieves commercialization and regulatory compliance with Arena Solutions' Arena QMS

Achieving Commercialization and Compliance Success

Potrero Medical is a predictive health company developing smart-sensor medical devices, including the Accuryn Monitoring System for automated urine output, intra‑abdominal pressure, and core temperature monitoring. As a highly regulated med‑tech startup preparing to commercialize its first product, Potrero relied on paper-based BOMs and manual engineering change and quality processes that wouldn’t scale or withstand ISO, FDA, and EU audit scrutiny.

Potrero implemented cloud-based Arena QMS (live within months) to centralize BOMs, ECOs, design controls, training, supplier management, and quality records with supplier access and validation support. The change delivered measurable gains: first‑review ECO approvals up ~25%, ECO cycle time down ~30%, training compliance from ~80% to >98%, component nonconformance down ~20%, and complaint cycle time reduced by 25%; Potrero also passed FDA inspection without 483s and achieved MDSAP/ISO 13485 audit success leading to CE marking.

Potrero Medical

Sanjay Banerjee

COO