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
IMDRF
The new article describes in detail the approach to be applied with respect to the third and fourth stages of the total product life cycle, as well as to the risk assessment in the context of transition between the stages. Table Of Contents: The International Medical...
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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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Jun 12, 2023
IMDRF
The new article highlights the aspects related to the first two stages of the total product life cycle, namely the initial development, when the product is being created, and support – the period that starts from the moment the product becomes available on the...
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Jun 12, 2023
FDA
The article describes in detail the regulatory approach to be applied with respect to contact lenses allowed for marketing and use in the US. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
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