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Latest ISO 13485 Stories

2014-07-08 08:32:11

SAN DIEGO, July 8, 2014 /PRNewswire/ -- ViaCyte, Inc. ("ViaCyte"), a privately held regenerative medicine company developing a cell therapy for treatment of type I diabetes, today announced it has received International Standards Organization (ISO) 13485:2003 certification, an internationally recognized quality standard for medical devices. ViaCyte's certification was awarded by the British Standards Institution (BSI), one of the world's leading certification bodies....

2014-06-17 23:13:08

New overview sheet showcases company’s implantable molding capabilities and success stories Butler, Wisconsin (PRWEB) June 17, 2014 MRPC, a single-source provider of medical device components and assemblies, recently released a new overview sheet highlighting their molded part design and tooling capabilities for implantable medical device components, those meant for long-term implementation inside the human body. MRPC began manufacturing implantables in 2008, when they built their...

2014-06-11 23:09:07

NewMedical Technology, Inc., announced today that it has achieved ISO 13485: 2003 certification for its quality management system, awarded on May 28th, 2014 from BSI Group America. NewMedical manufactures NewGel+, a line of silicone gel products developed for scar management. Northbrook, IL (PRWEB) June 11, 2014 “Achieving this certification is a significant milestone for NewMedical Technology,” said Michael Hanna, President and CEO. “We believe this achievement reinforces our...

2014-04-21 23:09:44

The United States’ Largest Medical Scale Manufacturer Meets Additional Worldwide Harmonized Standard of Quality and Conformity Webb City, MO (PRWEB) April 21, 2014 DETECTO, an industry leader in USA-made clinical weighing, has achieved EN ISO 13485:2012 certification for its design and manufacture of medical scales used in personal and professional settings. ISO 13485:2012 is the most recent iteration of the ISO 13485 quality standard for manufacturers of medical devices. This...

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...


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drawcansir
  • A blustering, bullying fellow; a pot-valiant braggart; a bully.
This word is named for Draw-Can-Sir, a character in George Villiers' 17th century play The Rehearsal.
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