May 24, 2023
FDA
The new article addresses the aspects related to special factors to be considered when developing a monitoring plan, the way centralized monitoring should be implemented, and also emphasizes the importance of maintaining blinding to mitigate risks associated with...
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May 24, 2023
Europe
The new article addresses the matters related to the regulatory status of the products based on artificial intelligence technology, regulated as medical devices. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA), a UK authority in the...
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May 1, 2023
Europe
The new article highlights the aspects related to cybersecurity for software-based medical devices intended to be marketed and used in the UK. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA), a UK regulating authority in the sphere of...
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Apr 17, 2023
IMDRF
The document highlights the key points regarding the regulatory approach to be applied with respect to cybersecurity-related matters associated with legacy medical devices. Table Of Contents: The International Medical Devices Regulators Forum (IMDRF), a voluntary...
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Apr 10, 2023
Europe
The new article highlights the aspects related to post market activities intended to ensure continuous safety and proper performance of medical devices allowed to be marketed and used in the country. Table of Contents The Medicines and Healthcare Products Regulatory...
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