As Outsourcing Gains Momentum, A&M BioMedical Bolsters Capacity to Meet Growing Demand
A&M BioMedical expands capacity at its Laguna Hills facility to meet growing demand for contract manufacturing, citing industry trends and its strong quality metrics.
As medical device OEMs increasingly turn to contract manufacturers to streamline operations and cut costs, the need for reliable, high-capacity production partners has never been more acute. Industry analysts project the global medical device contract manufacturing market to expand substantially over the next decade, fueled by demand for specialized capabilities and regulatory expertise. In response to this trend, A&M BioMedical, an ISO 13485-certified contract medical device manufacturer, today announced expanded production capabilities at its Laguna Hills, California facility.
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 facility is FDA-registered and features HEPA-filtered cleanroom environments for both sterile and non-sterile devices. The expansion positions A&M BioMedical to support production runs ranging from 150 to 150,000+ units per month, a capacity that aligns with the industry's shift toward outsourcing.
"OEMs are under immense pressure to reduce capital expenditures and focus on core competencies," said [Name], [Title] at A&M BioMedical. "Our expanded capacity reflects our commitment to supporting them with reliable and compliant manufacturing solutions. With over three decades of experience, we have developed processes that prioritize quality and efficiency for our clients."
The company's operational metrics underscore its readiness to meet this demand. A&M BioMedical reports a 98% first-pass yield rate and zero FDA 483 findings in recent inspections, indicating strong compliance with regulatory standards. Its quality management system is certified to ISO 13485, the international benchmark for medical device quality, and its cleanrooms are designed to meet strict requirements.
As the contract manufacturing landscape evolves, A&M BioMedical's expansion signals a strategic move to capture a larger share of the market. By offering end-to-end production lifecycle services—from process development and validation to full-scale manufacturing—the company aims to be a one-stop partner for OEMs seeking to bring devices to market efficiently.
"The industry is moving toward more collaborative partnerships," added [Name]. "We're investing in capacity and expertise to grow alongside our clients."
With the new capacity, A&M BioMedical is well-positioned to address both small-batch and high-volume needs, a flexibility that is increasingly important as device portfolios diversify. The company's Laguna Hills facility remains at the heart of its operations, and the expansion underscores its long-term commitment to the region and the industry.
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. Its services include medical device assembly, packaging, labeling, sterilization coordination, and supply chain management, supporting 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/