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Certification News

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136-150 of 196 results
BMDK facility wins ISO certification
By PBR Staff Writer
Biomedical Devices of Kansas (BMDK), a medical device contract manufacturing company, has obtained ISO 13485 certification.
Certification > News
ABS grants ISO certification to MMI imaging core lab services
By MDBR Staff Writer
ABS Quality Evaluations has granted ISO 9001:2008 certification to Medical Metrics' (MMI) imaging core lab services.
Certification > News
DeviceLab QMS wins ISO certification
By MDBR Staff Writer
The International Organization for Standardization has granted an ISO 13485 certification to DeviceLab's quality management system (QMS).
Certification > News
MDxHealth US laboratory facility wins CMS CLIA certification
By Lisa Mathew
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.
Certification > News
PrimeraDx obtains ISO 13485:2003 accrediation
By MDBR Staff Writer
PrimeraDx, a developer of molecular diagnostics assays, has obtained ISO 13485:2003 certification.
Certification > News
LABS donor testing wins AABB certification
By MDBR Staff Writer
LABS, a provider of implantable biologic products, has earned the American Association of Blood Banks (AABB) certification for its donor testing.
Certification > News
Delcath Galway facility wins ISO certification
By MDBR Staff Writer
Delcath Systems said its Galway, Ireland location's quality management systems, has met ISO 13485:2003 certification requirements.
Certification > News
Drummond awards ONC-ATCB certification to IOD Prism platform
By MDBR Staff Writer
IOD Incorporated has received ONC-ATCB certification for its Prism platform used for both ambulatory and inpatient practice type.
Certification > News
FDA grants CLIA waiver to BD Veritor System
By MDBR Staff Writer
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.
Certification > News
Konan Quality Management System wins ISO, CMDCAS accreditation
By MDBR Staff Writer
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.
Certification > News
Itamar expands presence in South America
By MDBR Staff Writer
Itamar Medical has received Brazilian Anvisa certification and entered into South America market for its products distribution including WatchPAT and EndoPAT.
Certification > News
URAC awards Case Management, Health Plan certification to Regence BlueShield
By MDBR Staff Writer
The US-based health care accrediting organization, URAC, has awarded Case Management and Health Plan certification to Regence BlueShield.
Certification > News
Nextremity Nextra Hammertoe system wins ISO, CE mark certification
By MDBR Staff Writer
Nextremity Solutions has received ISO 13485 and CE mark accreditation for its Nextra Hammertoe Correction System.
Certification > News
CAP awards certification to Almac Diagnostic Laboratory
By MDBR Staff Writer
The College of American Pathologists' (CAP) accreditation committee has certified Almac's Diagnostics Laboratory's Craigavon, UK facilities.
Certification > News
Sphere Medical receives EN ISO13485 scope extension
By MDBR Staff Writer
TUV SUD Product Service has granted a formal extension certification to Sphere Medical to include production of medical monitoring systems into its existing EN ISO13485 for design and development.
Certification > News
136-150 of 196 results