Jun 12, 2023
Europe
The new article highlights the aspects related to the general essential requirements, as well as the ones related to the design of medical devices to be followed in order for the latter to be allowed for marketing and use in the United Kingdom. Table of Contents The...
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Jun 12, 2023
Europe
The article provides a brief overview of an updated guidance document issued by the UK regulating authority with respect to software products subject to regulation as medical devices. Table of Contents The Medicines & Healthcare Products Regulatory Agency (MHRA),...
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May 24, 2023
Europe
The new article describes in detail special projects the authority intends to implement in order to introduce specific needs associated with the products based on innovative technologies. Table of Contents The Medicines and Healthcare Products Regulatory Agency...
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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 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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