About
A&M Biomedical Inc. is a woman-owned medical device manufacturer located in Laguna Hills, California. With over 30 years of experience, the company is FDA-registered and ISO 13485 certified. They specialize in contract manufacturing, process development, supply chain management, and distribution services for a variety of medical devices. The company operates in an ISO Class 7 cleanroom environment, producing both sterile and non-sterile products. Their services encompass all aspects of production and regulatory compliance, including documentation, quality procedures, assembly, and packaging. A&M Biomedical serves multiple sectors, such as respiratory, ophthalmic, cardiac, and dental devices, among others. Their capabilities include plastics assembly, electronic assembly, testing, and various bonding techniques. A&M Biomedical emphasizes quality and reliability, adopting a "Do it right the first time" approach. Their facilities are equipped with HEPA-filtered cleanrooms and ESD-controlled areas, staffed by highly trained operators dedicated to efficient production workflows and thorough quality documentation.
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Company Information
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Employees 10
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Founded 1994
Location
23042 Alcalde Drive, Laguna Hills, California, United States, 92653