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 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 22, 2023
Europe
The new article highlights the aspects related to serious adverse events, how they should be documented and reported, and the annual reporting requirements and procedures. Table of Contents The Swiss regulating authority in healthcare products (Swissmedic) has...
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Jun 19, 2023
Australia and Oceania
The new article provides a brief overview of the regulatory approach towards software-based products intended to be marketed and used in Australia. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of...
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Jun 15, 2023
Europe
The new article highlights the aspects related to the safety measures to be introduced by study sponsors, as well as the way adverse events associated with a medical device in question should be reported to the authority. Table of Contents The Swiss regulating...
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