A&M Biomedical in Laguna Hills, CA is a woman-owned, FDA Registered, ISO 13485 certified medical device manufacturer of sterile and non-sterile products. We partner with manufacturers to extend resources, add capacity, and minimize scale-up challenges. Our facilities offer a Class 7 cleanroom, skilled workforce, inventory management, and fulfilment. With 30 plus years of medical device manufacturing experience and an unwavering commitment to quality, A&M Biomedical is able to assist our customers in all aspects of production and compliance including: documentation (MPs/QPs/MTs/protocols), performing qualifications, receiving inspection, supply chain management, quality documentation (NCR/CAPA), process improvements, assembly, and packaging.