Avelo Achieves ISO 13485:2016 Certification for its Quality Management System

December 20, 2024. Avelo has successfully achieved ISO 13485:2016 certification, the global standard for Quality Management Systems (QMS) specific to the medical device industry. This marks a key milestone for the company, ensuring compliance with internationally recognized standards for quality, safety, and performance.

The certification was granted by BSI Group, one of the world’s leading notified bodies, following a rigorous audit of Avelo’s internal processes, product development, and quality controls. The audit confirmed that Avelo’s QMS meets all applicable regulatory requirements for the design, development, manufacture, and distribution of specimen receptacles supporting in-vitro diagnostic applications.

This achievement is a testament to the dedication of our team and the maturity of Avelo’s operations. It provides a solid foundation as the company moves toward broader clinical validation and regulatory clearances for its breath collection device.

About Avelo

Avelo AG, the Swiss breath aerosol diagnostic company, aims to revolutionize the diagnosis of Tuberculosis and lower respiratory tract infections causing pneumonia. Its breath collection device enables non-invasive collection of pathogens from breath and works with existing PCR tests. The novel device is designed for broad utility, similar to other sample collection technologies such as blood tubes. Founded in 2020, Avelo has a talented team experienced in business development, functional materials, product development, clinical research, molecular diagnostics, quality and regulatory, and is based in Zurich-Schlieren.