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 ...

The global IVD contract manufacturing services market is projected to grow at a CAGR of roughly 11% over the forecast period.

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 ...

This report segments the medical device contract manufacturing market by device type, class of device, service, and region. By IVD device type, within the category of In Vitro Diagnostic (IVD) devices ...

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 ...

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 ...

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 ...

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 ...

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 ...

Collaboration focuses on blood filters, leukoreduction, cleanroom assembly, and disposable medical manufacturing in ISO 7 & ISO 8 cleanrooms. By working with THY Precision (Hong Yang Precision), we ...

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 ...