Our ethylene oxide (ETO) sterilization capabilities for medical devices are designed to provide effective and reliable microbial control to sterilize a wide range of devices, ensuring that they meet the highest standards of sterility and safety.
Our comprehensive approach includes thorough validation and routine monitoring of sterilization processes, alongside detailed documentation and traceability to ensure compliance and provide assurance of device safety.
Sterilization Validation
Ensuring efficiency of our Ethylene Oxide (ETO) sterilization, we validate the process in compliance with ISO 11135 and ISO 10993 standards, safeguarding device sterility and safety throughout their lifecycle.
Routine Monitoring:
Continuous monitoring ensures that each sterilization cycle achieves the required sterility assurance levels and maintains product safety.
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We hold FDA (U.S. Food and Drug Administration) certification, we are trusted by COFEPRIS (Federal Commission for the Protection against Sanitary Risks in Mexico), ISO 13485 certification, and soon ANVISA (National Health Surveillance Agency of Brazil).
It is a specialized area where we provide all the guidance and support focused on medical entrepreneurship. Reach out and see how we can help enhance your growth in the medical manufacturing sector.
We not only have the infrastructure, experience, and trust of major regulatory institutions, but our location is also a significant competitive advantage. Monterrey is Mexico's most important industrial hub, our prices are globally competitive, and we are strategically located for logistics in relation to the United States, South America, and offer excellent rail and port connections for export.