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BMC Medical Manufacturing Secures FDA 510(k) Clearance

BMC Medical Manufacturing Secures FDA 510(k) Clearance for Client’s Innovative Medical Device

KEY POINTS:

● A U.S.-based company sought BMC as a contract manufacturer for its finalized medical device design.
● The original design was deemed unscalable for mass production while maintaining regulatory quality standards.
● BMC redesigned the device from the ground up, optimizing for manufacturability and compliance.
● The improved design successfully obtained FDA 510(k) clearance, enabling commercialization.

Miami, FL | Monterrey, MX | March 12, 2025 – BMC Medical Manufacturing proudly announces the successful FDA 510(k) clearance for a complex dual-balloon venous seclusion catheter designed for the treatment of superficial vein reflux. This milestone further strengthens BMC’s proven expertise in regulatory approvals and medical device manufacturing at scale.

A Partnership for Innovation & Compliance

A US-based R&D company approached BMC Medical Manufacturing seeking a contract manufacturer for its "finished" product design. Upon review, BMC’s engineering team determined that the original design was unbuildable at scale while maintaining the quality standards required for FDA clearance.

BMC’s Solution: Redesigning for Manufacturability

BMC quickly accepted the challenge and undertook a full redesign of the device, ensuring:

● Scalability & Manufacturability – Optimized for large-scale production.
● Regulatory Compliance – Meeting stringent FDA 510(k) requirements.
● Cost-Efficiency – Delivering a high-performance solution within a competitive timeframe.

This strategic approach allowed BMC to deliver a market-ready product, securing FDA approval and paving the way for commercial launch.

Industry Leadership & Expert Insight

Since 2010, BMC Medical Manufacturing has been at the forefront of medical device design, development, and manufacturing.

Mario Alberto Peña, General Manager at BMC Medical Manufacturing, emphasized:

“Our track record of providing class-leading medical device design, development, and manufacturing services is exemplified once again in this most recent FDA clearance. While this accomplishment may seem surprising to those unfamiliar with our capabilities as a company based in Monterrey, Mexico, it is simply part of our day-to-day commitment to excellence. We strive for complete customer satisfaction in every project.”

About BMC Medical Manufacturing

At BMC Medical Manufacturing, we provide end-to-end solutions for the design, development, testing, manufacturing, and logistics of medical devices. Our advanced design tools, cutting-edge manufacturing technologies, and rigorous quality systems ensure that every product meets the highest regulatory standards, including FDA, COFEPRIS, and ISO 13485.

With a Quality Management and Continuous Improvement System, supported by a team of highly qualified professionals, BMC continues to push the boundaries of innovation and compliance in the medical device industry.