FDA
The new article elaborates further on the requirements to be fulfilled by the entities involved in the activity considered remanufacturing based on considerations described in the previous article.
AIaMD
The article provides a general overview of the regulatory framework applicable to certain innovative products intended to be marketed and used in the UK.
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.
HSA
The new article describes in detail special regulatory requirements concerning software medical devices utilising Artificial Intelligence technology to ensure the specific risks associated with it are duly addressed.
