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 ...

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

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 ...

Medical device regulators launched new initiatives on harmonizing in vitro diagnostic (IVD) regulations and tweaking the Medical Device Single Review Program (MDSAP) for additional countries to ...

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 ...

Within the category of In Vitro Diagnostic (IVD) devices, IVD consumables are projected to experience the highest compound annual growth rate (CAGR) from 2024 to 2030. These consumables, which include ...

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 , ...

On 3 April 2020, the European Commission issued a guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices ("IVD") in the COVID-19 context. The Guidance ...

DUBLIN, April 13, 2021 /PRNewswire/ -- The "Medical Device Testing Market with COVID-19 Impact, By Services (Testing, Inspection, Certification), Sourcing, Technology ...