Sep 21, 2023
United States
The new article highlights the aspects related to the marketing applications related to the products incorporating software submitted under the various legal frameworks. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...
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Sep 21, 2023
MHRA
The new article describes in detail various specific aspects related to the regulatory requirements that in vitro diagnostic medical devices are subject to. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK regulating authority,...
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Sep 21, 2023
United States
The new article highlights aspects related to the description of the software to be included in submissions associated with a medical device using it. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the...
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Sep 21, 2023
United States
The new article highlights aspects related to the description of the software to be included in submissions associated with a medical device using it. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the...
Read More
Sep 21, 2023
MHRA
The new article highlights the aspects related to conformity assessment of In- Vitro Diagnostic medical devices. Table of Contents The Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical devices, has...
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