A&M Biomedical provides full-service contract manufacturing services to medical device customers. We work in advanced, HEPA-filtered, ISO certified facilities, employ a team of highly trained operators, and can validate each assembly process to ensure that it meets your high quality standards — and ours. We can produce your sterile and non-sterile devices — from initial prototype runs — to full scale production. Our team has a diverse background in medical devices and can provide quality-focused manufacturing services for manual assembly processes. We can accommodate any size production — from short runs and low volume runs — to high volume manufacturing. Depending on our customers’ needs, A&M Biomedical provide turnkey manufacturing services including supply chain management.
Our extensive experience has allowed us to establish meaningful connections with medical device professionals including engineers, fabricators and component suppliers. Working with our network of expert engineers and precision molders, A&M Biomedical can support all of your engineering needs including:
Sterilization and Validation
A&M Biomedical has alliances with certified sterilization facilities to provide our customers the optimal choice in sterilization processes and services. With input from our customers, we work with our sterilization partners to establish and manage the sterilization process, while ensuring all quality controls and documentation are maintained. We can provide turnkey product validation with all necessary documentation, product sample submissions and quarterly validation requirements.