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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.
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Min project size
Undisclosed
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Hourly rate
Undisclosed
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Employees
10 - 49
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Year founded
Founded 1994
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Our Story
We know the importance of ensuring the safety and efficacy of each and every product manufactured and distributed to the end user. We understand the challenges medical device companies face with ever evolving regulatory requirements and international standards. When you choose A&M Biomedical to manufacture your medical devices, in addition to our experience and expertise, you get the benefit of working with a group of people who will care about the quality of your product as much as you do.
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