Design Concept
Our design concept phase features advanced CAD, CAE and prototyping tools to transform your ideas into tangible product concepts. We emphasize iterative development and innovation to create precise, user-centered solutions that meet the highest safety and performance standards.
Product Development
With a focus on rapid prototyping and high-volume-based design, our product development process is geared towards bringing your ideas to life efficiently and effectively. From concept to production, we prioritize risk management and regulatory compliance to deliver safe and reliable medical devices.
• Rapid Prototyping - Additive
• High-Volume-Based Design
• Risk Management
Design Verification & Validation
Our design verification and validation services involve rigorous testing. Our process integrates comprehensive documentation and regulatory compliance to guarantee that each device meets both user needs and regulatory requirements, as well as that it meets the highest standards of quality and safety.
• Packaging and transport validation
• Sterilization validation
• Accelerated and real-time aging studies
• In-vitro testing
• In-vivo testing
• Biocompatibility (Third party service)
Your all-around answer to success
Turning visionary ideas into vibrant realities
Boosting your margins with strategic proximity and efficiency
Leave us your contact information and tell us about your project. You can also message us directly via the WhatsApp button to be attended by a BMC advisor.
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.