A&M Biomedical, a contract medical device manufacturing company based in Laguna Hills, California, has received ISO 13485:2003 certification from the National Standards Authority of Ireland, Inc (NSAI). A&M is a contract manufacturer for medical device companies and the ISO 13485 certification showcases the company's ability to manufacture medical devices that consistently meet customer and regulatory requirements.
"ISO 13485 is an international standard for medical device manufacturing quality and A&M should be proud of its achievement," says Chris Morrell, Vice President of NSAI. "By having ISO 13485 certification, A&M's customers can have peace of mind in the quality of their manufacturing and continuous improvement processes. We at NSAI hope that this certification opens up new markets for their manufacturing services."
"A&M Biomedical is a women and minority owned company in the heart of Southern California's medical device industry. We are committed to providing the highest quality manufacturing services to medical devices companies in Orange County and beyond. We knew that certification to ISO 13485 was necessary to demonstrate our commitment to quality." says Melissa Fontes, President of A&M Biomedical. "All of us at A&M are proud of this achievement and we hope that this certification will help us expand the market for our services."