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 ...

CDSCO releases MedTech Mitra's handbook for innovators in IVD medical devices segment: Our Bureau, New Delhi Wednesday, December 10, 2025, 08:00 Hrs [IST] The Central Drugs Standa ...

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 ...

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 ...

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 ...

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 ...

CDSCO launches new online risk classification module for medical devices to simplify approval procedures: Gireesh Babu, New Delhi Tuesday, December 9, 2025, 08:00 Hrs [IST] The Ce ...

On January 5, the US Food and Drug Administration (FDA) issued a new draft Guidance on Investigational IVDs Used in Clinical Investigations of Therapeutic Products. Based on concerns that drug ...

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 ...

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 ...