A&M Biomedical, Inc.
Directory listingDirectory record status
These labels describe this UNITEMFG record. They do not guarantee current capabilities, certifications, capacity, quality, or fit for a specific job.
- Directory listing
- Listed
- Ownership
- Claimed
- Last profile update
- Jul 13, 2026
About
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.
Specialties
Certifications & Quality
Business Certifications
Source-backed capabilities
These capability statements were observed in the linked manufacturer sources. They are source evidence, not a certification of the company or its current capacity.
Certification
- ISO 13485
Compliance & Quality Control | ISO 13485 Experts Skip to content Skip to footer [email protected] 949-916-4778 23042 Alcalde Drive, Suite A, Laguna Hills, CA 92653 About A&M Our Difference Our Team Women Owned Small Business Blog Services Compliance & Quality Control Manufacturing Supply Chain Management Fullfilment Quality Our Quality Policy Quality Management Process Clients Contact About A&M Our Difference Our Team Women Owned Small Business Blog Services Compliance &
A&M Biomedical, Inc. certification evidence ↗ Observed Aug 14, 2026