Avvio Medical Inc. has earned ISO 13485:2016 certification following an initial audit by the British Standards Institution (BSI), affirming its compliance with international medical device quality management standards.
CEO Paul Molloy described the achievement as more than a regulatory milestone, calling it a testament to Avvio’s vision of building a full-scale medical device company rooted in discipline, continuous improvement, and integrity. “Quality at Avvio isn’t just about checking boxes,” he said, noting that the company integrates its principles through storytelling, Lean and KAIZEN practices, and a Bushidō-inspired culture. Their internal motto, #ImproveEverything, reflects this commitment.
The certification positions Avvio to scale its manufacturing and design processes, pursue CE marking for global markets, and strengthen trust with partners, investors, and regulators, paving the way for its planned U.S. commercial launch in 2026.
Avvio’s flagship technology, the AVVIO ELS, uses microbubble-enhanced acoustic cavitation lithotripsy to treat kidney stones in outpatient and office-based settings. This minimally invasive system eliminates the need for general anesthesia, fluoroscopy, or expensive equipment, making it accessible for ambulatory surgery centers and cystoscopy suites.
Based in San Francisco, privately held Avvio Medical aims to transform urinary stone care by offering a fast, patient-friendly, and cost-effective solution that improves the treatment experience and broadens access across diverse clinical environments.
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