Quality

At the heart of our daily activities

At Selenium Medical, quality is one of our top priorities. In a demanding environment, maintaining high-quality standards is essential to guaranteeing patient safety and meeting industry expectations.

Our quality expertise

With over 15 years of experience, we have acquired thorough expertise in the standards and regulations applicable to medical devices. Strengthened by our international scope, this experience allows us to meet diverse requirements and guarantee strict compliance with standards across different global markets. We are ISO 9001 and ISO 13485 certified and registered with the FDA and ANVISA.

A high-performance Quality Management System

We rely on a structured and efficient Quality Management System, the result of collective efforts.
Our quality team strives to improve every day, ensuring that all steps are carried out in strict compliance with internal procedures, regulatory standards, and our clients’ specific expectations, from design to production, including industrialization and final inspection.