Given the amount of tests that have required certification under the new system, the EU has staggered the grace periods for different classes of devices already holding CE-IVD marks obtained under the ...
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 "Global IVD Raw Materials Market - Focused Insights 2024-2029" report has been added to ResearchAndMarkets.com's offering. The global IVD raw materials market is expected to reach a value of ...
The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286), that will, over the next four years, radically alter the landscape for laboratory-developed ...
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 evolving EU MDR and IVDR present key opportunities for companies to enhance compliance strategies, engage with notified bodies, and optimize market access. Staying informed and proactively ...
Medical Device Network on MSN
Registrar Corp purchases Spain’s CMC Medical Devices
Registrar Corp aims to integrate its network with CMC’s offerings to help medical device companies in bringing products to ...
"We're proud to welcome CMC Medical Devices to the Registrar Corp family," said Raj Shah, CEO of Registrar Corp. "Together, we offer medical device manufacturers a single partner to navigate complex ...
Precision Dx Products include Twist Precision Prep and Enrichment Dx Kit, Twist Precision Exome Dx Panel and Twist Precision Exome Dx Kit SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Twist ...
Becton, Dickinson (BD) management’s board approval to pursue a plan to separate BD's Biosciences and Diagnostic Solutions business from the rest of the organisation could reflect the “packaging up” of ...
Making an in vitro diagnostic assay has never been easy. Now with the global lab and supply chain and disruptions caused by the COVID pandemic, the development and manufacture of IVDs faces further ...
WALTHAM, Mass. & SAN DIEGO--(BUSINESS WIRE)--Revvity, Inc. (NYSE: RVTY), today announced a strategic agreement to commercialize an in vitro diagnostic (IVD) workflow solution for neonatal sequencing, ...
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