Avvio Medical Secures ISO 13485 Certification to Advance Kidney Stone Device Launch

Avvio’s Certification Marked a New Phase in Global Transformation

Image Credits: Avvio Medical

Announcement

Avvio Medical Inc., a private medical device company focused on treating kidney stone diseases, has received an ISO 13485:2016 certification for its audit, introduced by BSI (British Standards Institution). This is a recognition certification strengthening Avvio’s agreement with international standards to achieve the company’s commitment and accelerate medical device quality management systems. This will prove the thoroughness of operational and patient safety.

The ISO 13485 certification enables Avvio to qualify and stimulate design and manufacturing processes for marketing and pursuing CE, mainly to boost confidence in global partners, regulators, investors, and initiate international distribution. This is a valuable achievement and a step towards the company’s commercial launch in the US market, which will be held in 2026.

Avvio ELS

The Avvio ELS presents microbubble improved acoustic cavitation lithotripsy that provides kidney stone treatments. It’s a shift from the traditional operating room to an office-based environment and accessibility to outpatient care. This is a system enabling a small, single invasive therapy that is acceptable for cystoscopy suites and ambulatory surgery centers (ASCs) without the need for fluoroscopy, costly capital equipment, or general anesthesia. This is a compilation of innovation and advantage for both economic and clinical aspects, satisfying providers and patients.

Opportunities

Opportunities to prove in the field of healthcare market are what every company seeks. The investors are drawn towards internal development, innovation, and global growth that leads to acceptance, acquisitions, and valuable collaboration. The certification brings new responsibility for Avvio to perform and contribute the best in the healthcare sector. Avvio’s audit and commitment to improving the medical device quality management system is a hope to providers and patients alike. The certification is an official permit to elevate the design and manufacturing process in a required way without any external interruption.

Views and Statements

CEO of Avvio Medical, Paul Molloy, said, “This achievement serves regulatory requirement that demonstrates the company’s commitment to leading a full-scale medical device. With the sincere execution, precision, behavioral integrity, grounded mindset, and constant improvement builds a strong foundation at the operational level.” Further, “Avvio’s quality culture is not just a general exercise. We have represented innovation through structured messaging, principles based on KAIZEN and lean culture, Bushido, and storytelling format. We discussed our company’s internal motto with the BSI audit team. The motto says #improveEverything, and the certificate elaborates ‘that we live by it’.”