Our state-of-the-art production facilities, manufacturing team with more than 12 years of experience and rigorous quality control systems enable us to deliver high-quality products that meet or exceed regulatory requirements and industry standards. We adhere to strict regulatory standards such as ISO 13485 and Good Manufacturing Practices (GMP).
Partnering with us as your contract manufacturer ensures:
Design transfer
• Effective transfer of your product design into our production lines.
• Prototype development and validation services to ensure the manufacturability and functionality of your design before full-scale production.
Technology Transfer:
Transferring into our ISO 13485 certified Quality Management System ensures that the manufacturing processes are replicated accurately and efficiently while adhering to regulatory standards.
Storage Conditions:
Multiple warehouses to preserve the integrity of the raw materials and final product, including room temperature, controlled room temperature, cooling temperature, and freezing temperature.
Production Line Setup:
Production line set-up, including equipment qualifications, fixtures and tools development, to ensure optimal efficiency and quality.
Validations:
Rigorous validations to ensure the reliability and consistency of manufacturing processes, meeting predefined quality standards and regulatory requirements.
Continuous Monitoring:
Continuous monitoring of our processes through quality audits and ongoing training for operative personnel to maintain the highest standards of quality and compliance.
Your all-around answer to success
Turning visionary ideas into vibrant realities
Boosting your margins with strategic proximity and efficiency
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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.