Avelo Successfully Completes ISO 13485 Surveillance Audit

October, 27, 2025. Avelo has successfully completed its annual ISO 13485 surveillance audit conducted by BSI Group. The audit confirmed that Avelo’s quality management system continues to meet all applicable regulatory requirements for the design, development, manufacture, and distribution of specimen receptacles supporting in-vitro diagnostic applications.

Maintaining ISO 13485:2016 certification is a key milestone for medical device companies, ensuring compliance with internationally recognized standards for quality and safety.

This achievement underscores Avelo’s commitment to the highest standards of quality and regulatory compliance, forming a solid foundation for product development and future clinical validation efforts.

About Avelo

Avelo AG, the Swiss breath sampling 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 aerosols 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.