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Latest Quality management system Stories

2014-08-28 23:15:55

For 30 years, devicemakers have relied on The GMP Letter for the latest on the FDA's interpretation and enforcement of cGMPs and Quality Systems Regulation, information readers need to stay in compliance. Each monthly issue brings its readers updates on the FDA’s approach to facility inspections, changes to the EU’s unannounced inspections and the latest on joint inspections in these and other jurisdictions. Falls Church, VA (PRWEB) August 28, 2014 Subscribe to The GMP Letter...

2014-08-28 23:01:15

MME group was recently awarded ITAR certification for abiding by strict security and compliance regulations enforced by the U.S. Department of State. St. Paul, MN (PRWEB) August 28, 2014 ITAR certification ensures that a company operates in accordance with federal rules and regulations related to defense controls. “MME group meets ITAR requirements related to company structure, corporate policy, training, documentation and procedures,” said Bob Archambault, president and CEO of MME...

2014-08-28 08:28:09

Company Also Earns ISO 13485:2003 and EN ISO 13485:2012 Quality Certification HOUSTON, Aug. 28, 2014 /PRNewswire/ -- EMIT Corporation announced today that it has received CE-Mark for its HypothermX(®) Intravenous Fluid and Blood Warming Devices with sterile fluid paths, allowing for sales expansion into the European and other OUS markets. EMIT Corporation also announced that it has been awarded ISO 13485:2003 and EN ISO 13485:2012 quality certification from SGS United Kingdom Ltd,...

2014-08-21 23:15:46

Nel-Tech Labs, Inc. completes its ISO 9001:2008 recertification audit. Derry, NH (PRWEB) August 21, 2014 Nel-Tech Labs, Inc. is proud to announce it is has successfully completed its ISO 9001:2008 recertification audit. Nel-Tech Labs received its original ISO 9001:2008 certificate of registration on September 23, 2011 and this new recertification will bring us to the year 2017. To maintain our 3-year certification, NQA USA (an independent ISO registrar) performs yearly audits to ensure...

2014-08-06 12:28:46

DENVER, Aug. 6, 2014 /PRNewswire/ --The Commerce Department's National Institute of Standards and Technology (NIST) has named Sue Dunn and Jennifer Prinz, CEO and COO of Donor Alliance in Denver, to the Board of Examiners for the 2014 Malcolm Baldrige National Quality Award. The Baldrige Award is the nation's highest honor for organizational innovation and performance excellence. Appointed by the NIST Director, examiners are responsible for reviewing and evaluating applications...

2014-07-30 23:12:55

To survive in today's tough economy and ultra-competitive medical device market, manufacturers need a quality system that works from the get-go. Medical Device Quality & Compliance Institute 2014: Quality Systems and Design Control Training is three-and-a-half days of intensive training on compliance guidance and insight needed to meet FDA standards with confidence. Falls Church, VA (PRWEB) July 30, 2014 Medical Device Quality & Compliance Institute 2014: Quality Systems and...

2014-07-16 23:02:58

Certification awarded for the design, manufacture, sales and service of team communication products for demanding and challenging environments. (PRWEB) July 16, 2014 Sonetics®, a leading global provider of team communication products, today announced it has successfully passed the auditing requirements for ISO 9001:2008 and has been granted a certificate of registration for the “design, manufacture, sales and service of team communication products for demanding and challenging...

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....

2014-07-03 23:03:35

Quality standard ensures reliability and quality of TrakLok cargo security systems. Knoxville, TN (PRWEB) July 03, 2014 TrakLok, Inc., a cargo security firm specializing in trailer and container security, today announced it has successfully completed its fifth ISO-9001 audit. The internationally recognized quality management standard helps ensure that the company’s integrated lock, alarm and tracking system for trailers and containers is designed and produced so customers receive a...

2014-06-24 08:37:47

HAMILTON, N.J., June 24, 2014 /PRNewswire/ -- Sparta Systems, Inc., an industry pioneer and global leader in enterprise quality management solutions (EQMS), today announced it had received ISO 9001:2008 certification for the design and distribution of its software. The Company is the first and only major EQMS vendor to have received this certification. Certification to ISO 9001 requires an accredited third party auditing organization to thoroughly review the Company's internal...


Word of the Day
omphalos
  • The navel or umbilicus.
  • In Greek archaeology: A central boss, as on a shield, a bowl, etc.
  • A sacred stone in the temple of Apollo at Delphi, believed by the Greeks to mark the 'navel' or exact center-point of the earth.
'Omphalos' comes from the ancient Greek.
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