Associates Of Cape Cod, Inc. Achieves 13485:2003 Certification
Associates of Cape Cod, Inc. (ACC), a leading manufacturer of endotoxin and beta-glucan detection products, today announced that it has achieved ISO 13485:2003 certification for the Quality Management System in the East Falmouth Massachusetts manufacturing facility. This is the recognized standard "Medical Devices -- Quality Management Systems -- Requirements for Regulatory Purposes." The certification was achieved through National Standards Authority Ireland (NSAI), ACC's Notified Body.
ISO 13485:2003 certification recognizes successful compliance to the standards in the manufacture of medical devices. ACC has previously been certified to the ISO 9001:2000 standard and has now achieved the more rigorous medical device certification as part of its commitment to quality. The Company's customers now have the added assurance that ACC has established rigorous and effective processes for new product development, manufacturing, distribution, customer service and technical support.
"The ISO 13485:2003 certificate is further validation of the substantial progress achieved at our manufacturing facility," said AJ Meuse, Ph.D., President and CEO, ACC. Alison Skinner, Ph.D., Executive Vice President added, "This certification allows us to seek a CE mark in Europe for our Fungitell(TM) assay clinical diagnostic test, which will further endorse the quality of the product in markets outside the United States, and to expand into Original Equipment Manufacturing of medical devices for client companies."
About Associates of Cape Cod, Inc.
Associates of Cape Cod, Inc., based in East Falmouth, MA, is a leader in the field of bacterial endotoxin and beta-glucan detection and a major supplier to the pharmaceutical, medical device and clinical diagnostic industries. A wholly owned subsidiary of Seikagaku Corporation, the Company pioneered the humane use of horseshoe crab blood extract, Limulus Amebocyte Lysate (LAL), used in the testing of pharmaceuticals, medical devices and biologics, for the presence of potentially toxic endotoxins and glucans. In 1977, the Company was the first to receive an FDA license for the manufacture of this reagent. Our products are marketed throughout the world under the trade names Pyrotell, Glucatell, Pyrochrome, and Chromo-LAL. The Company offers contract testing for endotoxins and glucans, and has a research biochemicals division, Northstar BioProducts, specializing in carbohydrate chemistry. The Company also produces a clinical diagnostic test, Fungitell, for use by physicians to aid in the diagnosis of invasive fungal infections, and runs the CLIA approved Beacon Diagnostics Laboratory for patient sample analysis. For more information about Associates of Cape Cod, Inc. and our products, please visit our Web site at: www.acciusa.com or www.beacondiagnostics.com.
Source: Associates Of Cape Cod