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Last updated on April 17, 2014 at 10:14 EDT

Latest ISO 13485 Stories

2014-03-18 12:33:07

Company's Bench Suite of Genetics Information Management Solutions Now a Medical Device for Canadian Market BOSTON and LEUVEN, Belgium, March 18, 2014 /PRNewswire/ -- Cartagenia, the world leader in software-based workflow support for variant assessment, lab reporting, and integration of diagnostic knowledge-bases, today announced that it has received a Canadian medical establishment license for its Cartagenia Bench platform. Cartagenia Bench is a cloud-based platform that allows...

2014-02-21 12:24:40

PALM BAY, Fla., Feb. 21, 2014 /PRNewswire/ -- Syncron EMS, LLC (Syncron), a certified lean, world-class electronic manufacturing services provider headquartered in Palm Bay, Florida, today announced it has been successfully certified according to ISO13485:2003, the international standard for quality management systems for medical device manufacturing. Syncron was awarded certification by BSI, one of the world's leading certification bodies offering the latest in management systems...

2014-02-03 16:25:06

MILPITAS, Calif., Feb. 3, 2014 /PRNewswire/ -- CORWIL Technology, a Wafer Assembly and Test Services contract manufacturer supporting over 500 customers worldwide, announced today that its Quality Management System has passed the ISO 13485 audit for Medical Devices by the independent auditor, NSF-ISR. By passing the ISO 13485 audit, CORWIL has demonstrated that its Quality Management System meets customer and regulatory requirements to provide semiconductor assembly services for...

2014-01-09 08:27:38

ISO certifications position Luoxis for regulatory clearance and commercialization of the RedoxSYS(TM) diagnostic system. GREENWOOD VILLAGE, Colo., Jan. 9, 2014 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced that subsidiary Luoxis has received ISO 13485:2003 certification, an internationally recognized quality standard for medical devices and diagnostics. The company has also earned ISO 9001:2008 certification, a broadly established international quality...

2013-12-09 12:27:20

LOS ANGELES, Dec. 9, 2013 /PRNewswire/ -- Bruin Biometrics, LLC ("BBI") an innovative medical device manufacturer, announced today that it has received ISO 13485:2003 and EN ISO 13485:2012 certification, including CMDCAS certification, for its Quality Management System with its notified body SGS. Receipt of ISO 13485 certification demonstrates BBI's commitment to quality in the design, development, manufacture, and distribution of non-invasive diagnostic medical devices. The ISO...

2013-12-05 08:28:33

Facility in Compliance with ISO 13485 for Medical Device Kits RESEARCH TRIANGLE PARK, N.C., Dec. 5, 2013 /PRNewswire/ -- Marken announced today that their Singapore biological kit-building facility has now been certified to International Standards Organization (ISO) 13485 standards for the storage and distribution of medical devices. (Logo: http://photos.prnewswire.com/prnh/20110930/NY78064LOGO) This certification validates that Marken provides a Quality Management System for...

2013-12-03 12:20:29

Certifications recognize Boston Engineering's excellence in quality management of design and product development for medical, commercial, industrial and defense industries WALTHAM, Mass., Dec. 3, 2013 /PRNewswire/ -- Boston Engineering Corporation today announced it has been assessed and certified to meet the requirements of both the ISO 9001 and ISO 13485 standards. Certification assures the firm's quality management systems comply with requirements established by the International...

2013-11-15 23:25:21

August 28, 2013: Indilab, Inc. earns ISO 13485:2003 certification for U.S. manufacturing facility in Franklin Park, IL. Franklin Park, IL (PRWEB) November 15, 2013 Indilab’s ISO 13485:2003 registration audit was conducted by Perry Johnson Registrars, Inc. and the site was certified for the Design, Manufacture, and Distribution of Process Sterilization Indicators for Medical Device Sterilization. ISO 13485:2003 certification specifies processes for an organization's quality...

2013-11-12 23:19:05

Litron announces that it has received its ISO 13485:2003 certification effective October 15, 2013. Agawam, MA (PRWEB) November 12, 2013 “We’re extremely proud of achieving this goal and the hard work our staff puts in every day to ensuring we adhere to the highest quality standards. Our entire team from our quality control and quality assurance group, managers of our medical device assembly and laser services groups, to the workers processing our customer’s parts, are committed to...

2013-10-02 16:24:47

FALL RIVER, Mass., Oct. 2, 2013 /PRNewswire/ -- Millstone Medical Outsourcing is pleased to announce its recent hire of Kenneth Haire who will join the Millstone team as Director of Quality Systems in Olive Branch, MS. A veteran to the medical device industry, Mr. Haire brings twenty two years of experience to Millstone's renowned Quality team. He will be responsible for developing, coordinating, and maintaining company-wide compliance systems and working closely with customers to...