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Ben Kemp

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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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FDA Consensus Standards Update

FDA added three standards to the US Consensus Standards list in September for sterility.   Date of Entry Specialty Task Group Area Recognition Number Extent of Recognition Standards Developing Organization Standard Designation Number and Date Standard Title (click for recognition information) 09/09/2024 Sterility 14-460 Complete ISO 11140-1 Third edition 2014-11-01 Sterilization of health care products - Chemical indicators - Part…
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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Prepare for ISO 42001 webinar

There's still time to register for our upcoming webinar: Prepare for ISO 42001 – a framework for the management of AI. In this session we will discuss how organizations can proactively prepare for upcoming AI regulations by implementing the right processes and controls. This webinar is ideally suited for professionals across a wide range of industries that are looking to…
Ben Kemp
October 16, 2024
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