ISO 13485 Certification Granted to Avvio Medical

Avvio Medical Inc. has achieved ISO 13485:2016 certification after an initial audit conducted by BSI (British Standards Institution). This globally recognized certification demonstrates Avvio’s compliance with international standards for medical device quality management systems.

“This milestone is more than a regulatory requirement—it represents the fulfillment of our promise to stand up a full-scale medical device company,” Avvio Medical CEO Paul Molloy said. “Through disciplined execution, a culture of continuous improvement, and a mindset grounded in honor, behavioral integrity, and precision, we have built a foundation for scalable, global operations. The quality culture at Avvio is not just a box-checking exercise. We embed it through storytelling, structured messaging, and principles drawn from disciplines of Lean and KAIZEN and a culture Bushidō. As we shared with the BSI audit team, our internal motto is #ImproveEverything—and this certification illustrates that we live by it.”

The ISO 13485 certification enables Avvio to fully qualify its manufacturing and design processes for commercial scaling, pursue CE marking for international distribution, and reinforce confidence among global partners, investors, and regulators. The achievement is a major step toward the company’s upcoming 2026 commercial launch in the U.S. market.

The AVVIO ELS introduces microbubble enhanced acoustic cavitation lithotripsy that enables kidney stone treatments to move out of the traditional operating room and into more accessible outpatient and office-based settings. The system provides a single, minimally invasive therapy suitable for ambulatory surgery centers (ASCs) and cystoscopy suites, without requiring general anesthesia, fluoroscopy, or costly capital equipment.

Avvio Medical is a privately held medical technology company based in San Francisco and dedicated to improving urinary stone treatment. Its breakthrough platform aims to enhance the patient experience, reduce healthcare costs, and expand access to care by offering a fast, minimally invasive solution suitable for a wide range of clinical settings. The company’s system eliminates the routine need for general anesthesia or X-ray imaging, streamlining the treatment pathway for both patients and healthcare professionals.