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 18, 2023
IMDRF
The new article describes in detail the approach to be applied with respect to communication-related matters during the support stage of the total product life cycle. Table Of Contents: The International Medical Device Regulators Forum (IMDRF), an association 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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Jun 12, 2023
Europe
The new article highlights the aspects related to modifications to performance studies. In particular, the authority describes the approach to be applied when determining the regulatory status of modifications, as well as subsequent procedures to be followed by study...
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Jun 12, 2023
IMDRF
The new article describes in detail the approach to be applied with respect to the third and fourth stages of the total product life cycle, as well as to the risk assessment in the context of transition between the stages. Table Of Contents: The International Medical...
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