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 ...

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 ...

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 ...

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 ...

Illumina seems to be crossing all its t's and dotting all its i's when it comes to compliance with the new IVDR regulations in Europe. The company recently issued a press release announcing that it ...

ARLINGTON, Va.--(BUSINESS WIRE)--The Medical Device Innovation Consortium (MDIC) has announced the release of its Real-World Evidence Framework for regulatory decision-making for in vitro diagnostics ...

New Delhi: India’s medical device regulator, CDSCO in collaboration with the Indian Council of Medical Research (ICMR) has issued draft standard protocols for evaluating In-Vitro Diagnostics (IVDs) ...

In brief, LDTs are in vitro diagnostics (IVDs) that are intended for clinical use and are designed, manufactured, and used within laboratories that are certified under the Clinical Laboratory ...

The current European legislation for in vitro diagnostic medical devices (IVD) (Regulation 2017/746 or the IVDR) has created challenges not only for IVD manufacturers but also for pharmaceutical ...

The Central Drugs Standard Control Organisation (CDSCO) has revised the list of laboratories for conducting performance evaluation of In-Vitro Diagnostic (IVD) medical devices, adding seven ...

An overview of everything you need to know about EU legislation restricting hazardous substances from use in medical and IVD devices placed on the market in EU member states. Dr. Alex Martin Medical ...