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Accurate labelling of medical devices is vital for the safe and proper use of medical devices by patients and care givers and is a key
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Accurate labelling of medical devices is vital for the safe and proper use of medical devices by patients and care givers and is a key
The advent of artificial intelligence (AI) in healthcare promises to revolutionise patient care pathways, offering unprecedented advances in digital clinical support and decision-making systems. AI-driven
Implementing ISO 42001 for Ethical and Efficient AI Management is crucial for organizations striving to maintain high standards of ethical practices and operational efficiency in artificial intelligence. This comprehensive guide delves into the key principles of ISO 42001, providing insights into ethical AI governance, compliance strategies, and best practices for AI implementation. By adhering to these standards, organizations can ensure responsible AI development and deployment, fostering trust and reliability in AI systems.
Introduction In the fast-evolving landscape of digital health, the need for credible regulatory partners has never been more crucial. Deviceology Ltd (“Deviceology”) is proud to
Nobody writes a regulatory strategy that commits them to doing the bare minimum required by regulation to get a product to market and leave compliance activity
AI-driven systems have the potential to significantly improve patient assessments, treatment pathways, and diagnosis accuracy. However, their integration into healthcare settings requires a new focus for clinical digital risks necessitating careful consideration and a new thinking to address the challenges…
The MHRA recently released the following policy statement setting out a framework to allow devices with comparable regulator country (CRC) approvals access to the UK
Deviceology took part in update meetings with NHS England and the MHRA in the last fortnight, outlining the direction of travel for revised UK medical
AI-driven systems have the potential to significantly improve patient assessments, treatment pathways, and diagnosis accuracy. However, their integration into healthcare settings requires a new focus
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