Add Yahoo as a preferred source to see more of our stories on Google. The Medicines and Healthcare products Regulatory Agency (MHRA) is formalising its review process around in vitro diagnostics (IVD) ...

The current European legislation for in vitro diagnostic medical devices (IVD) (Regulation 2017/746 or the IVDR) has created challenges not only for IVD manufacturers but also for pharmaceutical ...

Research assistant Nicole Gebert contributed to this article. Part 1 of this article discussed the background and purpose of the EU In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), the definition ...

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 ...

Some IVD devices are provided as stand-alone devices--that is, they perform infection detection by autonomously following a pre-programmed decision-making process or rule. For each test performed by ...

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 ...

In vitro diagnostic (IVD) devices play a pivotal role in diagnosing and monitoring the health of millions of people globally. As such, ensuring the reliability, accuracy, and viability of a given ...

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 ...

insights from industryLaura NeaVP of Quality and Regulatory ManagementTecan In this interview, News-Medical talks to Laura Nea, Vice President of Quality and Regulatory Management at Tecan, about the ...

The value of data to the in vitro diagnostics industry has never been more apparent. At every corner of the healthcare industry, data is being used to help doctors make the best treatment decisions ...

More Lenient Guidelines May Inadvertently Lead to a Scarcity of Consented Samples Recently, no area has contributed more and increasingly complex layers to the bioethics debate than research employing ...

IVD Contract Manufacturing Services Market Overview: The global IVD contract manufacturing services market is projected to grow at a CAGR of roughly 11% over the forecast period. This expansion is ...