HAYWARD, Calif., June 14 /PRNewswire/ -- Alara Incorporated announced it has been certified to meet the International Standards Organization ISO 13485:1996 quality system standard for medical device companies.
Previously Alara was certified to ISO 9001/EN 46001. The company decided to pursue the demanding ISO 13485 standard in order to meet requirements for licensing its products in Canada. The standard focuses specifically on quality systems for medical device companies and imposes rigorous requirements on design controls, process controls, traceability, and record retention, all of which are critical for this industry. Diane King, vice president of regulatory affairs, noted, "The ISO 13485 certification ensures that our products meet the European Union's Medical Device Directives and Canada's quality system requirements. We can be sure of producing high quality devices only by having consistent manufacturing processes and quality systems in place."
As a result of the new certification, Alara will continue to expand its international distribution channels for MetriScan(R). Distribution in both Europe and worldwide is expected to grow through partnerships with over 21 separate country-specific distributors including Canada where Alara will now actively promote the product.
About The Alara MetriScan
MetriScan is a compact, tabletop device that allows physicians to perform in-office bone mineral density (BMD) testing on patients at risk for osteoporosis. The device scans the patient's fingers in less than one second to estimate BMD; a complete print-out is available in just two minutes.
About Alara Incorporated
Alara designs, manufactures and markets radiographic imaging products based on storage phosphor technology. Its first product, the DenOptix(TM) filmless x-ray dental imaging system, is used by thousands of dental practitioners around the world and is distributed by Gendex Dental Systems of Des Plains, IL. MetriScan is Alara's second digital imaging device, and is used for bone mineral density testing. CRystalView, a new product for Alara, is a high quality desktop computed radiography system. For additional information, please visit http://www.alara.com/.
CONTACT: Trudy Hsu of Alara Incorporated, +1-510-265-6241, firstname.lastname@example.org