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 ...
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 ...
The new Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) approved by the European Union in May 2017 tightens requirements in an effort to create a more transparent and ...
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 ...
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 ...
In vitro diagnostic (IVD) devices for the detection of the Bacillus species were assigned to class II on Friday, following the release of a US Food and Drug Administration (FDA) final rule. The IVDs ...
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