Persei vivarium obtains ISO 13485 certification, accrediting quality management systems for medical devices

by Patricia Domínguez, June 26, 2024

After a complete and exhaustive auditing process, our company, Persei vivarium, has obtained the ISO 13485 certification that accredits the organization’s quality management system for the design, development, and commercialization of medical device software.

The ISO 13485 standard provides a foundation that is applicable to companies in the sector of medical devices and related services, and includes those specifications for quality management systems that demonstrate the ability of the organization to provide medical devices that are adapted to the requirements of the client and applicable regulations. The principal elements of the standard are, among others, a focus on risk management, legal and regulatory compliance, continuous improvement, as well as the management and measurement of the product’s operation and procedures.

This certification guarantees that our company has in place a solid system for quality management and complies with international regulatory requirements in the medical device industry. In addition, it ensures that the organization has the necessary expertise to introduce safe medical devices to the market.

For Persei vivarium, achieving this certification represents another step forward in our commitment to safety and quality, as well as the continuous improvement of our systems and processes. It allows us to offer products and services that meet market needs and comply with regulations in an ever-evolving and highly demanding environment.

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