EU
The article highlights the key points related to the regulatory framework for reporting requirements in the context of certain studies medical devices are subject to.
FDA
The new article describes in detail the approach to be applied with respect to data collection and reporting in the context of animal studies.
DRAP
The new article describes in detail the relevant inspection process, highlighting the key points to be considered by the parties involved.
HSA
The new article provides an overview of the activity controls introduced to ensure operations conducted by medical device manufacturers (software developers) align with the relevant regulatory requirements.
HSA
The new article provides recommendations and clarifications on a broad range of matters with a primary focus on the ones related to cybersecurity considerations for software medical devices intended to be marketed and used in Singapore.
FDA
The new article provides additional clarifications regarding various testing methodologies to be used when assessing the thermal effect caused by medical devices when used for the intended purpose, as well as the risks associated with it.
