A&M Biomedical, Inc.

A&M BioMedical is an ISO 13485-certified contract medical device manufacturer based in Laguna Hills, California. With over 30 years of manufacturing experience, we provide turnkey contract manufacturing services including medical device assembly, packaging, labeling, sterilization coordination, and supply chain management. Our FDA-registered facility features HEPA-filtered cleanroom environments for both sterile and non-sterile medical devices. We support production runs from 150 to 150,000+ units per month with a 98% first-pass yield rate and zero FDA 483 findings. From process development and validation to full-scale production, A&M BioMedical is your trusted manufacturing partner.