Medical Device Qualified Supplier Directory
A & M Biomedical, Inc. Company Profile
Qualifications: ISO 13485, FDA Registered
Markets Supplied: North America, Europe, Worldwide
For 20 years, A&M Biomedical Inc. has provided high-quality manufacturing outsourcing services with small company efficiency and accessibility. ISO 13485 certified, FDA registered and FDB licensed. A&M Biomedical is certified Small and Woman owned company committed to managing all aspects of production, with expertise in regulatory compliance, quality control, and documentation. Our facility includes an ISO Class 7 (10,000) Clean Room and ESD controlled Production Area. Process capabilities include plastics assembly, electronic and electrical assembly, continuity testing, voltage verification (AC/DC), current leakage testing, soldering, wire harness assembly, solvent and UV bonding, ultrasonic welding, assembly and packaging. We employ a staff of highly skilled, trained technicians. Additionally, we maintain an advanced quality and regulatory control system and offer engineering management, complete supply chain management and sterilization management. Contact us today to see how we can help with your assembly and packaging needs.