From 28 April, IVDs used clinical trials will be subject to an upfront assessment by the MHRA as part of a Clinical Trial of ...

RALEIGH, N.C.--(BUSINESS WIRE)--Veranex, the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry, announced today that it has acquired an ...

CDSCO issues draft guidance document for online submission of import applications for IVD medical devices: Gireesh Babu, New ...

HiMedia is dedicated to maintaining high safety, quality, and performance standards for in-vitro diagnostic products used in healthcare. This commitment significantly enhances the well-being of ...

The Food and Drug Administration (FDA) published its long-awaited Final Rule that will regulate laboratory developed tests (LDTs) as in vitro diagnostic (IVD) medical devices. FDA published a ...

In vitro diagnostics (IVDs) are a mainstay of modern medicine. People of all ages and their healthcare providers rely on these tests to determine the risk of a wide range of chronic and acute diseases ...

This article is the third in Microbiologics’ series on Optimal QC in the Clinical Laboratory. Previously, in this series we highlighted the importance of external and third-party quality control ...

MILFORD, Mass.--(BUSINESS WIRE)--Waters Corporation (NYSE: WAT) today announced that the Waters ® ACQUITY UPLC ® I-Class IVD/Xevo ® TQ-S micro IVD System is now manufactured as a U.S. FDA Class I ...

Professional services consultancy, Procorre is urging the Medical Devices industry to take action ahead of the new ISO13485:2016 International Standard and MDD & IVD ‘Recast’ which become mandatory in ...

CHICAGO, Sept. 3, 2020 /PRNewswire/ -- According to the new market research report "Medical Device Testing Market with COVID-19 impact, By Services (Testing, Inspection , Certification), Sourcing , ...

Regulatory oversight has instead been exercised by the NAFDAC pursuant to its general mandate under the NAFDAC Act (Cap N1, ...