HSA
The new article describes the key steps and requirements associated with pre-market product registration in the context of software medical devices intended to be marketed and used in the country.
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.
FDA
The new article describes in detail the approach to be followed when evaluating medical devices impacting, intentionally or unintentionally, the temperature of human tissues.
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