Jun 12, 2023
IMDRF
The new article addresses the aspects related to establishing efficient communication between medical device manufacturers and healthcare providers with respect to medical devices used and also provides definitions of the most important terms and concepts. Table Of...
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Jun 12, 2023
FDA
The new article highlights the aspects related to specific tests to be conducted by medical device manufacturers in order to demonstrate compliance with the applicable regulatory requirements. Table of Contents The Food and Drug Administration (FDA or the Agency), the...
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Jun 2, 2023
IMDRF
The new article addresses the aspects related to the initial design development stage in terms of design and controls intended to ensure a medical device’s continued safety and proper performance. In particular, the article outlines the main responsibilities of...
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May 24, 2023
FDA
The new article addresses the aspects related to the content of a monitoring plan, as well as the follow-up procedures and the way they should be documented. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the...
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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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