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) ...

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 ...

Dublin, Nov. 13, 2020 (GLOBE NEWSWIRE) -- The "Medical Device & IVD Regulatory Affairs Outsourcing Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2020 - 2030" report has ...

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 ...

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 ...

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 ...

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its responses to the consultation on Medical Device Regulations: Routes to market and in vitro diagnostic devices ...

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 ...

RNA sequencing provides a comprehensive view of biological information, offering deeper insights into disease mechanisms, including improved fusion detection. As a powerful tool in research and ...

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 ...

OSLO, Norway--(BUSINESS WIRE)--OncoImmunity has become the first company to obtain a CE-IVD mark for the clinical use of a machine-learning based neoantigen prediction technology. This quality ...

The Council has endorsed key updates to the law on medical devices that will help prevent shortages and ease the transition to greater transparency and access to information. The regulation approved ...