LAGUNA HILLS, Calif. — August 6, 2026 — A&M BioMedical, an ISO 13485-certified contract medical device manufacturer, today announced that its expanded Laguna Hills, California facility now supports production runs from 150 to 150,000+ units per month while maintaining a 98% first-pass yield rate and zero FDA 483 findings in recent inspections. The expansion enhances the company's ability to serve original equipment manufacturers seeking compliant, high-volume manufacturing solutions.
The company, with over 30 years of manufacturing experience, provides turnkey services including medical device assembly, packaging, labeling, sterilization coordination, and supply chain management. Its FDA-registered facility features HEPA-filtered cleanrooms for both sterile and non-sterile devices, designed to meet strict regulatory requirements.
The expansion comes as the global medical device contract manufacturing market is projected to grow significantly over the next decade, driven by demand for specialized production capabilities and regulatory expertise. A&M BioMedical's services span the full production lifecycle, from process development and validation to full-scale production.
"Our expanded capacity reflects our commitment to supporting medical device companies with reliable and compliant manufacturing solutions," said [Name], [Title] at A&M BioMedical. "With over three decades of experience, we have developed processes that prioritize quality and efficiency for our clients."
The company highlighted its operational metrics, including the 98% first-pass yield rate and absence of FDA 483 observations, which indicate strong regulatory compliance. These metrics are critical for clients seeking to reduce capital expenditures and focus on core competencies.
A&M BioMedical's cleanrooms are engineered to handle both small-batch and high-volume manufacturing needs, accommodating a wide range of production volumes. The quality management system is certified to ISO 13485, the international standard for medical device quality management.
About A&M BioMedical, Inc.: A&M BioMedical is a contract medical device manufacturer based in Laguna Hills, California. The company is ISO 13485-certified and operates an FDA-registered facility with HEPA-filtered cleanrooms. Services include medical device assembly, packaging, labeling, sterilization coordination, and supply chain management. A&M BioMedical supports production runs from 150 to 150,000+ units per month.
Media Contact
Contact person: Melissa Fontes, CFO
Company: A&M Biomedical, Inc.
Phone: +1 (949) 916-4778
Website: https://ambiomedical.com/