May 24, 2023
FDA
The new article describes in detail the way a risk-based approach should be applied with respect to clinical trials involving human subjects, paying special attention to the initial risk assessment to be carried out by the party responsible for a clinical...
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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 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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Mar 23, 2023
Europe
The new article describes in detail the aspects related to the existing premarket requirements and the improvement they require. Table of Contents The Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of healthcare...
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Mar 2, 2023
Europe
The new article highlights the aspects related to the classification of medical devices the UK authority intends to improve by the virtue of amending the existing regulatory framework. Table of Contents The Medicines and Healthcare products Regulatory Agency (MHRA),...
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