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Is your medical software market-ready?

Sade Sobande, lead QA/RA consultant As medical devices become increasingly interconnected, their software applications must also be safe and effective when placed on the market. In this on-demand webinar, Sade Sobande, lead QA/RA consultant at Emergo by UL, provides insight into how medical device regulations, standards, and guidance are keeping pace with the proliferation of medical device software. Learn about:…
Ben Kemp
November 1, 2024
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NIHR Research Delivery Network Launched

The NIHR’s Research Delivery Network (RDN) launched on 1 October and marks a new chapter in the optimisation and delivery of health and care research in England. The RDN is a new organisation which has been set up to respond to the changing requirements of the health and care research system. Having taken over from the NIHR Clinical Research Network, the RDN…
Ben Kemp
October 16, 2024
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CLSI EP12

Evaluation of Qualitative, Binary Output Examination Performance, 3rd Edition This guideline includes descriptions of the types of qualitative, binary output examinations and procedures for evaluating their performance. This edition of the document was corrected in February 2024. Read the correction notices by accessing the link above, and learn more about our correction process here. Find out more here.
Ben Kemp
October 16, 2024
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Section 524B: Navigating Healthcare Cybersecurity Compliance

As the intersection of healthcare and cybersecurity continues to play a vital role in safeguarding patient data and the integrity of medical technologies, it is crucial for professionals in the healthcare sector to stay well-informed about legislative directives such as Section 524B. Are you a professional involved in medical software development and medical technology device manufacturing? Then this on-demand webinar…
Ben Kemp
October 16, 2024
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Brazil IVD News: Regulation updates

To help you navigate the Brazilian Health Regulatory Agency's (ANVISA) latest updates for in vitro diagnostics (IVDs) and the implications for your healthcare products, we highly recommend you review this detailed report by Patricia Urakawa, Senior Consultant of Regulatory Affairs at Emergo by UL. This invaluable resource explains several critical updates to RDC 830/2023 that you should be aware of,…
Ben Kemp
October 15, 2024