DNV, the independent global assurance and risk management provider, is partnering with Korean AI-driven blood and cancer diagnostics company Noul to certify their malaria diagnosis, blood cell ...

IVDs are essential for disease detection, personalized treatment, and public health, driving growth in the global diagnostics ...

Navigating The MDR and IVDR and Best Strategies for Compliance SAE Media Group is proud to announce the launch of the Medical Devices and IVD Conference, taking place on 14 – 15 November 2022 in ...

The Global Harmonization Task Force (GHTF), an international harmonization body whose duties are soon to be subsumed by the International Medical Devices Regulators' Forum (IMDRF), has released a ...

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 ...

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 ...

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 ...

Kehua Bio offers significant market opportunities in IVD devices, leveraging partnerships for R&D innovation in diagnostics and point-of-care testing. Its established manufacturing and sales presence ...

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 ...

Great Britain is entering a new era of MedTech regulation, with major pre-market changes expected that are designed to ...