New York, Nov. 10, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Medical Device & IVD Regulatory Affairs Outsourcing Market – Global Industry Analysis, Size, Share, ...
The MDR and MDR updates will have a profound impact on the medical device industry, bringing certain products into regulatory scope that were previously excluded, introducing new manufacturing ...
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Tempus AI Enhances AI-Driven Diagnostics With Multiple FDA Approvals
In the first nine months of 2025, Tempus AI Inc. TEM achieved several key regulatory milestones that strengthened its position in AI-driven diagnostics. In September 2025, the company received FDA 510 ...
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 ...
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 ...
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 ...
Subject to certain exceptions, medical devices have historically not been heavily regulated in South Africa. Prescriptive requirements for medical devices were not in force and advertisers and ...
Navigating The MDR and IVDR and Best Strategies for Compliance SAE Media Group is proud to announce the launch of the Medical Devices and IVD Conference, taking place on 14 – 15 November 2022 in ...
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