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...
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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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Sep 20, 2023
MHRA
The new article addresses the aspects related to the conformity assessment procedures in vitro diagnostic medical devices should undergo in order to ensure their safety and proper performance. Table of Contents The Medicines and Healthcare Products Regulatory...
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Sep 20, 2023
Bahrain
The article provides an overview of the regulatory requirements for custom-made medical devices intended to be used in Bahrain and also describes in detail the documentation to be submitted by an interested party when applying for marketing approval. Table of Contents...
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