Certification
Genetic Australian laboratory wins CMS CLIA certificate
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The Centers for Medicare and Medicaid Services (CMS) has granted clinical laboratories improvements amendments (CLIA) certificate of compliance to Genetic Technologies' Melbourne, Australia laboratory.
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The Centers for Medicare and Medicaid Services (CMS) has granted clinical laboratories improvements amendments (CLIA) certificate of compliance to Genetic Technologies' Melbourne, Australia laboratory.
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InfoGard grants certification to DR Systems eHR for medical imaging
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InfoGard, a certification body of the office of the national coordinator (ONC-ATCB), has granted a complete ambulatory electronic health record (EHR) certification to DR Systems' e|HR meaningful use for medical imaging solution.
Certification > News Vita Needle quality management system wins ISO certification By
has received the ISO 9001:2008 and medical device manufacturing standard, ISO 13485:2003, for its quality management systems.
Certification > News
InfoGard, a certification body of the office of the national coordinator (ONC-ATCB), has granted a complete ambulatory electronic health record (EHR) certification to DR Systems' e|HR meaningful use for medical imaging solution.
Certification > News Vita Needle quality management system wins ISO certification By
has received the ISO 9001:2008 and medical device manufacturing standard, ISO 13485:2003, for its quality management systems.
Certification > News
Latest Certification News and Insight
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BMDK facility wins ISO certification
Biomedical Devices of Kansas (BMDK), a medical device contract manufacturing company, has obtained ISO 13485 certification.
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ABS grants ISO certification to MMI imaging core lab services
ABS Quality Evaluations has granted ISO 9001:2008 certification to Medical Metrics' (MMI) imaging core lab services.
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DeviceLab QMS wins ISO certification
The International Organization for Standardization has granted an ISO 13485 certification to DeviceLab's quality management system (QMS).
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MDxHealth US laboratory facility wins CMS CLIA certification
The Centers for Medicare and Medicaid Services (CMS) has granted Clinical Laboratory Improvements Amendments (CLIA) certification to MDxHealth's 13,448 ft² clinical laboratory facility in Irvine, California, US.
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Certification > News
PrimeraDx obtains ISO 13485:2003 accrediation
PrimeraDx, a developer of molecular diagnostics assays, has obtained ISO 13485:2003 certification.
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LABS donor testing wins AABB certification
LABS, a provider of implantable biologic products, has earned the American Association of Blood Banks (AABB) certification for its donor testing.
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Delcath Galway facility wins ISO certification
Delcath Systems said its Galway, Ireland location's quality management systems, has met ISO 13485:2003 certification requirements.
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Drummond awards ONC-ATCB certification to IOD Prism platform
IOD Incorporated has received ONC-ATCB certification for its Prism platform used for both ambulatory and inpatient practice type.
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FDA grants CLIA waiver to BD Veritor System
The US Food and Drug Administration (FDA) has granted a 510(k) and clinical laboratory improvement amendments (CLIA) waiver clearance to Becton, Dickinson and Company's (BD) Veritor System.
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Konan Quality Management System wins ISO, CMDCAS accreditation
Konan Medical's Quality Management System has received accreditation from both ISO 13485:2003 and the Canadian Medical Device Conformity Assessment System (CMDCAS), by Intertek, a notified body based in the UK.
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