STOCKHOLM , Aug. 29, 2022 /PRNewswire/ -- Devyser has today been certified under the new, more comprehensive IVD Regulation that came into force on May 26, 2022. The certification, issued by the ...
Historically, pharmaceutical and diagnostic companies in the U.S. have inhabited parallel regulatory universes. Although both sets of firms are overseen by the FDA and are subject to some identical ...
The Food and Drug Administration (“FDA” or “agency”) intends to issue a notice of proposed rulemaking in August 2023 that will “make explicit” that laboratory developed tests (LDTs) are devices under ...
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 ...
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 ...
Bringing notified bodies (NBs) into a med-tech regulatory system has proven to be no mean feat in the European Union, but the U.K. Medicines and Health Care Products Regulatory Agency (MHRA) seems not ...
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 ...
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