Aug 11, 2023
IMDRF
The new article highlights the aspects related to the “End of Support” stage of the total product life cycle and outlines the key points to be taken into consideration at this stage in order to ensure the proper performance of medical devices as well as the safety of...
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Aug 10, 2023
Europe
The guidance addresses aspects related to the safety measures to be developed and introduced by the parties responsible for performance trials in order to ensure the safety of study participants while maintaining the accuracy and reliability of the study results....
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Jun 27, 2023
IMDRF
The new article highlights the aspects related to the limited support stage of the total product life cycle and provides recommendations to be followed by the parties involved. Table Of Contents: The International Medical Device Regulators Forum (IMDRF), a voluntary...
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Jun 26, 2023
Europe
The new article describes in detail the approach to be applied with respect to notifications, databases, liability insurance, and other aspects related to performance studies involving in vitro diagnostic medical device Table of Contents The Swiss regulating authority...
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Jun 25, 2023
IMDRF
The new article highlights the aspects related to the support stage – a period when healthcare providers use a medical device while being fully supported by its manufacturer. Table Of Contents: The International Medical Device Regulations Forum (IMDRF), a...
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