M4D LLC

M4D LLC is an ISO 13485:2016-certified and FDA-registered medical device manufacturer specializing in the design, development, prototyping, testing, validation, and full-scale manufacturing of endovascular technologies. The company operates three dedicated cleanrooms across 12,000 sq. ft of GMP-compliant facility space, including ISO Class 8 (100K) cleanroom areas. M4D serves as a strategic partner for medical device innovators, providing comprehensive contract manufacturing services from initial concept and design through regulatory compliance and commercialization. With over 70 years of combined industry experience, M4D specializes in complex catheter manufacturing capabilities including catheter winding, marker band swaging, segment fusing, and hydrophilic coating application. The company is committed to quality-driven innovation and maintains rigorous supply chain management and regulatory compliance protocols to support the development of therapies that improve patient outcomes.