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 ...

DNV, the independent global assurance and risk management provider, is partnering with Korean AI-driven blood and cancer ...

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 ...

ARLINGTON, Va.--(BUSINESS WIRE)--The Medical Device Innovation Consortium (MDIC) is seeking public comment on its draft framework, Real-World Clinical Evidence Generation: Advancing Regulatory Science ...

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 ...

CHICAGO, April 21, 2021 /PRNewswire/ -- According to the new market research report "Medical Device Outsourced Manufacturing Market by Device Type (IVD (Equipment, Consumable), Diabetes, Respiratory, ...

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 ...

Dublin, Jan. 06, 2026 (GLOBE NEWSWIRE) -- The "Shanghai Kehua Bio-engineering Co Ltd (002022) - Product Pipeline Analysis, 2025 Update" has been added to ResearchAndMarkets.com's offering. Shanghai ...

Within the category of In Vitro Diagnostic (IVD) devices, IVD consumables are projected to experience the highest compound ...

Dublin, May 02, 2018 (GLOBE NEWSWIRE) -- The "Contract Manufacturing in IVD: Market Analysis" report has been added to ResearchAndMarkets.com's offering. In vitro diagnostics markets rely on ...

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 ...