Persei vivarium successfully completes the annual ISO 13485 surveillance audit, reaffirming its commitment to the quality of medical devices

by Patricia Domínguez, April 9, 2025

Our company, Persei vivarium, has successfully passed the annual surveillance audit for its ISO 13485 certification. This guarantees that the medical devices offered by the company comply with rigorous regulation and are adapted to the needs of the clients.

ISO 13485 is the international standard that regulates Quality Management Systems (QMS) in the medical devices industry, compiling the requirements that companies must meet in order to satisfactorily provide these types of products to their clients. In this way, this certification, which Persei vivarium obtained last year, demonstrates that the company has strong internal processes with a quality management system for the design, development, and commercialization of medical device software.

This successful audit demonstrates the company’s determination to maintain continuous improvement and the ability to continue offering quality healthcare products, with a clear focus on patient safety, while complying with the highest regulatory standards in the sector.

The annual continuation of this certification is part of Persei vivarium´s commitment to continue offering products and services that are secure, reliable, and aligned with the needs and expectations of the market, creating a high impact on patients’ health and quality of life.