Spanish
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Quality AssuredStrengthening our global compliance with ISO 13485, COFEPRIS,
FDA and now ANVISA for excellence in medical device manufacturing. -
Cost-Efficient
EnvironmentSkilled Labor, Scalable Capacity and In-house EtO Sterilization -
Ideally
LocatedMonterrey, Nuevo Leon is a thriving industrial zone in Mexico directly adjacent to
the largest medical device market in the world, the US.
Engineered quality
"Our technology enhances competitiveness"
About us
BMC is a global contract manufacturer for medical devices of the highest quality, with competitive cost advantages in an ideal business location. We assemble, package, and sterilize in-house (EtO) to improve efficiency. Situated in Monterrey, Nuevo León, a major industrial hub strategically located near the U.S. border.
Vision
To be the trusted contract manufacturing partner —delivering compliant, quality-assured, manufacturing-focused design solutions that de-risk programs, accelerate time-to-market, and strengthen total product economics.
Mission
We build long-term partnerships by combining disciplined quality, manufacturing-focused design expertise, and efficient execution—reducing risk and accelerating launch with unmatched value.
Quick and Efficient Technology Transfers
This is our core model, focused to manufacture from Class I to Class III devices.
Line Ramp-up
Capacity and infrastructure ready to scale.
Expert Support
Engineering, quality, and production working together to ensure smooth transfers.
Services
Contract Manufacturing
Delivering high-quality medical devices through scalable, ISO 13485—certified contract manufacturing processes, fully compliant with FDA, ANVISA and COFEPRIS standards.
Research and Development
Practical engineering for transfer, design-for- manufacturing, fixtures, and fast pilots—focused on getting your line running.
Quality Management
Guided by ISO 13485 standards, our Quality Management System ensures rigorous testing, regulatory compliance, and continuous improvement to guarantee the safety and reliability of every device.
Sterilization
In-house ETO sterilization offers a proven, reliable method to ensure the safety and sterility of medical devices.
Validation
Rigorous validation of equipment, processes, sterilization, and final products to ensure consistent performance and reliability at every stage.
Medical Device Approval
We conduct testing, prepare comprehensive documentation, and support regulatory submissions to achieve medical device approvals from global health authorities.
Product Certification
Approval from regulatory authorities to ensure compliance...
Contract Manufacturing
State-of-the-art facilities for the manufacturing of medical devices...
Certifications
ISO 13485: Medical Devices QMS
Enables us as manufacturers of medical devices and related services to increase our access to international markets.
FDA Registration
Commitment to compliance with regulatory standards for medical devices in the United States.
COFEPRIS NOM-241 Medical Devices GMP
Certified by the Government of Mexico as an organization that ensures good manufacturing practices for medical devices.
ANVISA GMP Medical Devices Certification
Certified by the Brazilian Health Regulatory Agency, ensuring compliance with national standards for the manufacturing, safety, and quality of medical devices.
Frequently Asked Questions
Why manufacture in Mexico?
Nearshoring in Mexico reduces costs, shortens lead times, and offers proximity to the U.S., while maintaining FDA and COFEPRIS compliance.
Why partner with us?
We are ISO 13485 certified, FDA registered, and COFEPRIS compliant, with validated processes and scalable production for medical devices.
What types of devices can you manufacture?
We specialize in endovascular and cardiovascular devices, as well as a wide range of medical device components and assemblies.
Do you support startups and small companies?
Yes, we help startups and emerging companies scale from prototypes to full production with tailored solutions.
What certifications and approvals do you hold?
ISO 13485 QMS, FDA Registration, and COFEPRIS NOM-241 GMP certification.
How do you protect client IP?
We sign strict NDAS and follow secure processes to protect intellectual property at every stage.
Can I visit your facilities?
Yes, we welcome audits and site visits by clients and regulatory authorities.
Do you offer validation and sterilization services?
Yes, including process validation, equipment validation, and ETO sterilization.
What are your typical lead times?
Lead times vary by project, but nearshoring allows us to shorten development and production cycles significantly compared to overseas manufacturing.
How do I start a project with you?
Contact us to schedule a meeting. We'll review your project requirements and provide a tailored proposal.
News
ANVISA otorga BPF para dispositivos I–IV en BMC
Obtuvimos la certificación BPF ANVISA para dispositivos de las clases I, II, III y IV, cubriendo toda clase de dispositivos médicos.
Elevating Mexico’s Medical Device Industry
Leaders from health authorities and biomedical engineering institutions visited BMC
BMC drives clinical success of catheter
At BMC, we specialize in contract manufacturing for the medical device industry, partnering with innovators to transform early-stage concepts into market-ready solutions.
End-to-end contract manufacturing with advanced design support, scalable production technologies, and certified quality systems to bring your medical devices to market with speed and compliance.
Clients
Our clients
We have been partnering with BMC Medical Manufacturing for several years, and their team of skilled engineers consistently impresses us with their technical expertise and attention to detail. They have an exceptional ability to turn complex ideas into practical solutions, ensuring that our products meet the highest quality standards. Their commitment to innovation and excellence has made a significant impact on our product development process.
Sintra Medical Team
Our experience with BMC Medical Manufacturing has been outstanding from start to finish. Their skilled engineers work seamlessly with our team, bringing a wealth of knowledge and innovative thinking to every project. The synergy between their R&D and manufacturing teams ensures that our devices are not only designed for optimal performance but also manufactured with precision and efficiency. Their commitment to quality and customer satisfaction makes them an invaluable partner in our product development journey.
Uphill Medical Team
We couldn’t be happier with the manufacturing services provided by this company. Their state-of-the-art facilities, combined with a meticulous approach to quality control, ensure that every device is produced to the highest standards. The team’s deep understanding of regulatory requirements and commitment to continuous improvement gives us confidence that our products are not only safe but also reliable. We are confident that their exceptional manufacturing capabilities will allow us to scale efficiently and meet the market demand with ease.
Basis Medical Team
Our Team
ALBERTO PEÑA
General Manager
OSMEL PÉREZ
Head of Operations
MARIAN RODRÍGUEZ
Head of R&D
ESTRELLA ROMÁN
Health Manager
ANA LUCÍA GONZÁLEZ
Validation Supervisor
ADELAIDA MORENO
Production Supervisor
ANA YANCY PADRÓN
Accounting Administrator
SAMANTHA AGUILAR
Head of Human Resources
ROBERTO HERNÁNDEZ
Maintenance Engineer
DANNA SALAZAR
Head of Marketing
MARTIN TYLER
Business Development
MITZI AVENDAÑO
Regulatory Affairs Responsible
Contact
End-to-end contract manufacturing with advanced design support, scalable production technologies, and certified quality systems to bring your medical devices to market with speed and compliance.
USA
Location: 2916 N Miami Ave. Ste 621. Miami FL 33127, USA.
Phone: +1 (786) 668 7715
MEXICO
Location: Blvd TLC, Parque Industrial Millenium Apodaca, N.L. Mexico.
Phone: +52 81 8371 7614
Mail: info@bmcmm.com
Hours: Mon - Fri de 9:00 a 18:00 hrs. UTC-06:00
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